Resilient interpositional arthroplasty device

ABSTRACT

This disclosure is directed to a resilient interpositional arthroplasty implant for application into a joint to pad cartilage defects, cushion, and replace or restore the articular surface, which may preserve joint integrity, reduce pain and improve function. The implant may endure variable joint compressive and shear forces and cyclic loads. The implant may repair, reconstruct, and regenerate joint anatomy, and thereby improve upon joint replacement alternatives. The walls of this invention may capture, distribute and hold living cells until aggregation and hyaline cartilage regrowth occurs. The implant may be deployed into debrided joint spaces, molding and conforming to surrounding structures with sufficient stability so as to enable immediate limb use after outpatient surgery. Appendages of the implant may repair or reconstruct tendons or ligaments, and menisci by interpositional inflatable or compliant polymer arthroplasties that promote anatomic joint motion.

This application claims the benefit of U.S. Provisional Application No.61/530,324 filed on Sep. 1, 2011, and relates to U.S. patent applicationSer. No. 12/460,703, filed Jul. 23, 2009; and International PatentApplication No. PCT/US2010/058977, filed Dec. 3, 2010, which claims thebenefit of U.S. Provisional Application No. 61/267,750, filed Dec. 8,2009, and U.S. patent application Ser. No. 12/460,730, filed on Jul. 23,2009; and International Patent Application No. PCT/US2011/021674, filedJan. 19, 2011, which in claims the benefit of U.S. ProvisionalApplication No. 61/297,698, filed Jan. 22, 2010; and InternationalPatent Application No. PCT/US2011/021673, filed Jan. 19, 2011, whichclaims the benefit of U.S. Provisional Application No. 61/297,697, filedJan. 22, 2010, all of which are incorporated herein by reference intheir entirety.

BACKGROUND OF THE INVENTION

This invention relates to arthroplasty, and more particularly, to animplant for use in arthroplasty when hyaline articular cartilage isdamaged, it breaks down and joint space is lost. Inflammatory enzymessuch as from the Cox-1, Cox-2 and/or 5-Lox systems are released andloose bodies form adding to the degradation of joint function. Suchjoint damage is conventionally treated by physical therapy, analgesics,pain medication and injections. When these treatments fail, thetraditionally accepted treatment option is arthroplasty implantation orreplacing the joint with an artificial joint construct. Currentarthroplasty techniques typically use “plastic and metal” implants thatare rigid and which ultimately fail due to loosening or infection ordebris from wear. Conventional materials for the artificial jointcomponents include chrome-cobalt-molybdenum alloy (metal) and highmolecular weight polyethylene (plastic). Each is often fixed by acement-like mixture of methyl methacrylate to the ends of the bones thatdefine the joint that is the subject of the arthroplasty, or coated witha surface that enables bone in-growth. Current hip joint replacementstypically last about 10-15 years and knee replacements typically lastabout 5-10 years. Ankle joint replacements, on the other hand, are notvery successful, and often fail in the first several years aftersurgery.

Conditions requiring arthroplasty include traumatic arthritis,osteoarthritis, rheumatoid arthritis, osteonecrosis, and failed surgicalprocedures.

SUMMARY OF THE INVENTION

The present invention is directed to an orthopedic implant configuredfor deployment between opposing members of a joint structure thataddresses many of the shortcomings of prior artificial joints. Thearthroplasty implants embodying features of the invention are configuredto preserve joint motions while removing the pain and dysfunctionfollowing the development of arthritis or joint injury. The arthroplastyimplant in accordance with the present invention achieves improvedphysiologic motion and shock absorption during gait and acts as aresilient spacer between moving bones during limb movement. The combinedcharacteristics of the implant include anatomic design symmetry,balanced rigidity with variable attachment connections to at least oneof adjacent normal structures, and durability which addresses and meetsthe needs for repair or reconstruction thus far missed in the prior art.The implant should be secured to at least one of the bones of the jointstructure.

Provided herein is a resilient implant for implantation into human oranimal joints to act as a cushion allowing for renewed joint motion. Theimplant may endure variable joint forces and cyclic loads while reducingpain and improving function after injury or disease to repair,reconstruct, and regenerate joint integrity. The implant may be deployedin a prepared debrided joint space, secured to at least one of the jointbones and expanded in the space, molding to surrounding structures withsufficient stability to avoid extrusion or dislocation. The implant mayhave opposing walls that move in varied directions, and an inner spacefilled with suitable filler to accommodate motions which mimic orapproximate normal joint motion. The implant may pad the damaged jointsurfaces, may restore cushioning immediately and may be employed torestore cartilage to normal by delivering regenerative cells.

Provided herein is a resilient interpositional arthroplasty implant forapplication into human or animal joints to pad cartilage defects,cushion joints, and replace or restore the articular surface, preservingjoint integrity, reducing pain and improving function. The implant mayendure variable joint compressive and shear forces, and millions ofcyclic loads, after injury or disease requires intervention. The implantmay repair, reconstruct, and regenerate joint anatomy in a minimallymorbid fashion, with physiologic solutions that improve upon the rigidexisting joint replacement alternatives of plastic and metal. In caseswhere cells have been used for joint resurfacing requiring massiveperiosteal harvesting for containment, the polymer walls of someembodiments of the implant can capture, distribute and hold living cellsuntil aggregation and hyaline cartilage regrowth occurs. The implant maybe deployed into a prepared debrided joint space, molding and conformingto surrounding structures with sufficient stability to avoid extrusionor dislocation. Appendages of the implant may serve to repair orreconstruct tendons or ligaments. Appendages of the implant may serve torepair or reconstruct fibrocartilage as in menisci, or the labrumtissues of hips or shoulders. The implant may have opposing walls thatmove in varied directions, and an inner space, singular or divided,filled with suitable gas, liquid, and/or complex polymer layers asforce-absorbing mobile constituents, such than robust valid and reliablejoint motion is enabled.

Provided herein is a resilient orthopedic implant configured fordeployment between a first bone and at least one second bone of a joint,the implant comprising a balloon comprising a first portion that isconfigured to engage the first bone of the joint, a second portion thatis configured to engage at least one second bone of the joint, a sideportion connecting the first portion and the second portion, in whichthe side portion facilitates relative motion between the first portionand the second portion, and an interior that is optionally inflatablewith a first inflation medium; and a first appendage configured tocouple the balloon to the first bone of the joint. As used herein aballoon may also and/or alternatively be called a balloon. In theembodiments wherein the balloon is not inflated, the uninflated balloonmay accommodate movement between portions of the balloon wall or a firstwall of the balloon and a second wall of the balloon. Alternatively oradditionally, the uninflated balloon may provide the opportunity forlater inflation following implantation. In some embodiments, thematerials of the implant allow for internal expansion. In otherembodiments, material layers may be fixed in apposition so as toencourage strength and anti-creep, as with a mesh. In certainembodiments, the fixed layer itself has pockets containing gas or gel(e.g. viscolubricants) or liquid or a pharmacologic. In otherembodiments, the implant walls are contiguous having no discernablepockets, vacuoles or chambers.

Provided herein is a resilient orthopedic implant configured fordeployment between a femur and a tibia of a knee joint, the implantcomprising a balloon comprising a first portion that is configured toengage a medial condyle and a lateral condyle of the femur of the kneejoint, a second portion that is configured to engage the tibia of theknee joint, a side portion connecting the first portion and the secondportion, in which the side portion facilitates relative motion betweenthe first portion and the second portion, and an interior that isoptionally inflatable with a first inflation medium; and a firstappendage configured to couple the balloon to the femur of the kneejoint.

In some embodiments, the implant comprises at least one attachmentelement in the intercondylar notch. In some embodiments, the implantcomprises at least one attachment element in the medial region of theintercondylar notch. In some embodiments, the implant comprises at leastone attachment element in the lateral region of the intercondylar notch.In some embodiments, the implant comprises at least one attachmentelement superiorly at the distal end of the femur anteriorly. In someembodiments, the implant comprises at least one posterior reignconfigured to cinch up the implant from inside a posterior intercondylarnotch toward a connection site around the femur. In some embodiments,the implant comprises at least one suture-like lanyard configured tocinch up the implant from inside a posterior intercondylar notch towarda connection site around the femur.

In some embodiments, at least two of first portion, the second portion,and the side portion are contiguous. In some embodiments, the firstportion comprises a first wall, the second portion comprises a secondwall, and the side portion comprises a side wall.

In some embodiments, the implant comprises an inflation port incommunication with the interior of the balloon for inflation of theinterior of the balloon with the first inflation medium. In someembodiments, the interior comprises a plurality of inflatable chambers.In some embodiments, a first chamber of the plurality of individuallyinflatable chambers is adapted to be inflated with the first inflationmedium, and a second chamber of the plurality of individually inflatablechambers is adapted to be inflated with a second inflation medium. Insome embodiments, the first inflation medium imparts at least one ofrigidity in the implant and cushion in the implant. In some embodiments,there is no inflatable chamber and the cushioning is a result ofcompliant materials of the walls themselves

In some embodiments, the implant comprises a second appendage couplingthe balloon to at least one of: the femur of the joint and the tibia ofthe joint.

Provided herein is an implant configured for deployment between a femurand a tibia of a knee joint, the implant comprising a balloon comprisinga first portion that is configured to engage at least one condyle of thefemur of the knee joint, a second portion that is configured to engagethe tibia of the knee joint, a side portion connecting the first portionand the second portion, in which the side portion facilitates relativemotion between the first portion and the second portion, and an interiorthat is optionally inflatable with a first inflation medium; and a firstappendage configured to couple the balloon to the femur of the kneejoint.

In some embodiments, the at least one condyle is the medial condyle. Insome embodiments, the at least one condyle is the lateral condyle. Insome embodiments, the retropatellar surface could be the anatomic regionpadded. In some embodiments, the tibia-medial or lateral or both iscapped. In certain knee implant embodiments, the implant articulatesagainst cartilage of the first bone, second bone, and/or the third bone

In some embodiments, the balloon is at least one of: at most about 1.5cm in diameter, at most about 1.75 cm in diameter, at most about 2 cm indiameter, at most about 2.25 cm in diameter, at most about 2.5 cm indiameter, at most about 2.75 cm in diameter, at most about 3 cm indiameter, at most about 3.25 cm in diameter, at most about 3.5 cm indiameter, at most about 3.75 cm in diameter, at most about 4 cm indiameter, at most about 4.25 cm in diameter, at most about 4.5 cm indiameter, at most about 4.75 cm in diameter, at most about 5 cm indiameter, at most about 5.25 cm in diameter, at most about 5.5 cm indiameter, at most about 5.75 cm in diameter, at most about 6 cm indiameter, at most about 6.25 cm in diameter, at most about 6.5 cm indiameter, at most about 6.75 cm in diameter, at most about 7 cm indiameter, at most about 7.25 cm in diameter, at most about 7.5 cm indiameter, at most about 7.75 cm in diameter, at most about 8 cm indiameter, at most about 3 cm in length along the longest length of theballoon, at most about 3.25 cm in length along the longest length of theballoon, at most about 3.5 cm in length along the longest length of theballoon, at most about 3.75 cm in length along the longest length of theballoon, at most about 4 cm in length along the longest length of theballoon, at most about 4.25 cm in length along the longest length of theballoon, at most about 4.5 cm in length along the longest length of theballoon, at most about 4.75 cm in length along the longest length of theballoon, at most about 5 cm in length along the longest length of theballoon, at most about 5.25 cm in length along the longest length of theballoon, at most about 5.5 cm in length along the longest length of theballoon, at most about 5.75 cm in length along the longest length of theballoon, at most about 6 cm in length along the longest length of theballoon, 6.25 cm in length along the longest length of the balloon, atmost about 6.5 cm in length along the longest length of the balloon, atmost about 6.75 cm in length along the longest length of the balloon, atmost about 7 cm in length along the longest length of the balloon, atmost about 7.25 cm in length along the longest length of the balloon, atmost about 7.5 cm in length along the longest length of the balloon, atmost about 7.75 cm in length along the longest length of the balloon,and at most about 8 cm in length along the longest length of theballoon.

In some embodiments, the first portion comprises a first wall, thesecond portion comprises a second wall, and the side portion comprises aside wall.

In some embodiments, the implant comprises an inflation port incommunication with the interior of the balloon for inflation of theinterior of the balloon with the first inflation medium. In someembodiments, the balloon is punctured to inflate the interior of theballoon with the first inflation medium. In some embodiments, theballoon is self-sealing. In some embodiments, the balloon isself-sealing upon inflation of the interior of the balloon with thefirst inflation medium. In some embodiments, the implant comprises aseal capable of closing the interior of the balloon. In someembodiments, there is no balloon and inflation into a wall of theimplant expands the implant with a compressible material. In someembodiments, inflation is achieved via a needle or cannula that deliversthe inflation medium such as lubricating materials or medications or acombination thereof, or other inflation mediums. In some embodiments,despite addition of an inflation medium, there is no ballooning effector change in thickness in the device, as the inflation medium itselffills empty spaces in the wall (or walls) into which it is delivered.

In some embodiments, the implant comprises an inflation port incommunication with the interior of the balloon for inflation of theinterior of the balloon with the first inflation medium. In someembodiments, the interior comprises a plurality of inflatable chambers.In some embodiments, a first chamber of the plurality of individuallyinflatable chambers is adapted to be inflated with the first inflationmedium, and a second chamber of the plurality of individually inflatablechambers is adapted to be inflated with a second inflation medium. Insome embodiments, the first inflation medium imparts at least one ofrigidity in the implant and cushion in the implant. In some embodimentsthe chambers are constructed as part of a trabecular polymer frameworkor honeycomb or foam or alveolar network. The chambers may be adapted toincrease the surface area of available polymer for disbursement orabsorption.

In some embodiments, the implant comprises a second appendage couplingthe balloon to at least one of: the femur of the joint and the tibia ofthe joint. In some embodiments, the implant comprises at least oneattachment element in the intercondylar notch. In some embodiments, theimplant comprises at least one attachment element in the medial regionof the intercondylar notch. In some embodiments, the implant comprisesat least one attachment element in the lateral region of theintercondylar notch. In some embodiments, the implant comprises at leastone attachment element superiorly at the distal end of the femuranteriorly. In some embodiments, the implant comprises at least oneposterior reign configured to cinch up the implant from inside aposterior intercondylar notch toward a connection site around the femur.In some embodiments, the implant comprises at least one suture-likelanyard configured to cinch up the implant from inside a posteriorintercondylar notch toward a connection site around the femur.

In some embodiments, the implant is fabricated to resemble a certainanatomic region over which the implant is stretched or pulled intoplace. The implant then may settle into its angle of repose via inherentelasticity. In some embodiments the ambient environment of the joint viaexposure to serum or temperature or acidity has a specified effect onthe implant materials such as increasing the implant malleability thataffects implant performance.

Provided herein is an implant configured to patch a defect of a bone ofa knee joint, the implant comprising a balloon configured to engage thedefect of the bone of the knee joint and comprising an interior that isoptionally inflatable with a first inflation medium; and a firstappendage configured to couple the balloon to the bone of the kneejoint.

In some embodiments, at least one of the appendage and the balloon areconfigured to replace cartilage.

In some embodiments, the balloon is at least one of: at most about 0.5cm in diameter, at most about 0.75 cm in diameter, at most about 1 cm indiameter, at most about 1.25 cm in diameter, at most about 1.5 cm indiameter, at most about 1.75 cm in diameter, at most about 2 cm indiameter, at most about 2.25 cm in diameter, at most about 2.5 cm indiameter, at most about 2.75 cm in diameter, at most about 3 cm indiameter, at most about 3.25 cm in diameter, at most about 3.5 cm indiameter, at most about 3.75 cm in diameter, at most about 0.5 cm inlength along the longest length of the balloon, at most about 0.75 cm inlength along the longest length of the balloon, at most about 1 cm inlength along the longest length of the balloon, at most about 1.25 cm inlength along the longest length of the balloon, at most about 1.5 cm inlength along the longest length of the balloon, at most about 1.75 cm inlength along the longest length of the balloon, at most about 2 cm inlength along the longest length of the balloon, at most about 2.25 cm inlength along the longest length of the balloon, at most about 2.5 cm inlength along the longest length of the balloon, at most about 2.75 cm inlength along the longest length of the balloon, at most about 3 cm inlength along the longest length of the balloon, at most about 3.25 cm inlength along the longest length of the balloon, at most about 3.5 cm inlength along the longest length of the balloon, at most about 3.75 cm inlength along the longest length of the balloon, and at most about 4 cmin length along the longest length of the balloon.

In some embodiments, the interior comprises a plurality of inflatablechambers. In some embodiments, the interior comprises a plurality ofindividually inflatable chambers. In some embodiments, a first chamberof the plurality of individually inflatable chambers is adapted to beinflated with the first inflation medium, and a second chamber of theplurality of individually inflatable chambers is adapted to be inflatedwith a second inflation medium.

In some embodiments, the balloon or a chamber thereof may be secondarilyinflated, deflated, or a combination thereof in situ.

In some embodiments, the implant comprises an in-growth matrix on atleast a portion of the implant adjacent the femur. In some embodiments,the in-growth matrix comprises living chondrocytes. In some embodiments,the implant is configured to release the chondrocytes over time. In someembodiments, the implant comprises a bioabsorbable polymer configured torelease the chondrocytes over time. In some embodiments, the implantcomprises a polymer configured to release the chondrocytes over time,wherein the polymer is not bioabsorbable. In some embodiments, thein-growth matrix comprises cells. In some embodiments, the in-growthmatrix comprises at least one of: stem cells, differentiated cells,pluripotent cells, post-mitotic cells. In some embodiments, the cellsrestore an articular surface of the femur. In other embodiments, thecells repair an articular surface of the femur. In some embodiments, theimplant comprises a bioabsorbable polymer configured to release thecells over time. In some embodiments, the implant comprises a polymerconfigured to release the cells over time, wherein the polymer is notbioabsorbable. In some embodiments, the in-growth matrix comprises atleast one of: autologous cells, allograph cells, and xenograph cells torestore an articular surface of the femur. In some embodiments, thein-growth matrix comprises at least one of: autologous cells, allographcells, and xenograph cells to repair an articular surface of the femur.In some embodiments, the in-growth matrix comprises a pharmacologicsubstance. In some embodiments, the patch implant comprises a matrixthat is coated with a hydrophilic or a hydrophobic polymer. In someembodiments the patch is vessicular with or without matrices in the wallcomponents. In certain embodiments, the patch is a solid compliantmaterial. In some embodiments, the walls or material construct isresponsive or performs in a dynamic fashion to exogenous joint forces.For non-limiting example, in bone under normal physiologic stress ofbearing weight, calcification yields sufficient bone density so as todeter fracture. However, in circumstances wherein prolonged dearth ofweight bearing stress is produced by immobilization the bone becomesosteoporotic and pathologic. The implant herein may have smart featuresto adjust to stimulate healing and tissue regeneration. In someembodiments such materials can be composed of macromolecules ordendritic connections that regulate permeability and transfer ofadjacent media.

In some embodiments, the implant comprises couplers that couple theappendage to the femur. In some embodiments, the coupler isbioabsorbable. In some embodiments, the coupler is at least one of: ascrew, a snap, a washer, a suture, a suture anchor, a rivet, a staple, astaple having teeth, a magnet, an electromagnet, a microminiaturetransmitter that regulates implant fixation or performance responsive topatient need as perceived by the patient or a care giver, a stabilizer,a glue, a hook, a wire, a string, a lasso, a lanyard, a spike, andcombinations thereof. The implant may also and/or alternatively beattached via bone in-growth. In some embodiments, the implant isattached via bone in-growth as described in Vasanji A, In vivo bonegrowth assessment in preclinical studies and clinical trials, Bonezone,2012, p. 12-17, herein incorporated by reference in its entirety.

In some embodiments, the implant comprises a pharmacologic agent. Insome embodiments, the pharmacologic agent is on a surface of the implantadjacent the femur. In some embodiments, the pharmacologic agent isreleased from the implant over time. In some embodiments, thepharmacologic agent is released from within the implant over time. Insome embodiments, the pharmacologic agent is released from within theballoon over time. In some embodiments, the agent is released as acombination of vessicular and matrix origins using internal or externalstimuli from normal or exogenous sources.

In some embodiments, the first inflation medium imparts rigidity in theimplant. In some embodiments the implant comprises a bone cement. Insome embodiments, the implant comprises methyl methacrylate. In someembodiments, the first inflation medium imparts cushion in the implant.

In some embodiments, the inflation medium is compressible. In someembodiments, the inflation medium comprises a viscolubricant. In someembodiments, the inflation medium comprises a pharmacologic substance.In some embodiments, the inflation medium comprises an NSAID. In someembodiments, the inflation medium comprises chondrocytes. In someembodiments, the inflation medium comprises cells.

In some embodiments, at least a portion of the implant is configured toanneal to a periphery of a cartilage defect.

In some embodiments, the implant comprises vacuoles of pharmacologicsubstances. In some embodiments, the vacuoles may be on a bone-engagingportion of the implant. In some embodiments, the implant comprisesbubbles comprising an active substance such as a pharmacologic substanceor other active agent. In some embodiments, the active agent comprisesat least one of: stem cells, growth factors, antibiotics, antifungals,antituberculous, antitumor, antigout agents and viscolubricants. In someembodiments, the active agent comprises iatrigenically gene mutatedcells.

In some embodiments, the implant comprises enzyme absorptive microscopicsponges that could be sucked out or evacuated at or around the time ofimplant delivery to the joint.

In some embodiments, the interior comprises a honeycomb structure. Insome embodiments, the interior comprises a mesh structure. In someembodiments, the interior comprises a sponge structure. In someembodiments the implant comprises a sponge structure. In someembodiments the implant comprises a compliant membrane.

In some embodiments, the implant comprises spaces filled with an activesubstance such as a pharmacologic substance or other active substance.In some embodiments, the implant comprises spaces for deliverables(e.g., biologics, antibodies, cells, pharmacologic substances,biomolecules, molecules, compounds). In some embodiments, the implantcomprises spaces for compressibles (e.g., gas, air). In someembodiments, the spaces comprise nanovesicles. In some embodiments, thenanovasicles comprise deliverables (e.g., biologics, antibodies, cells,pharmacologic substances, biomolecules, molecules, compounds). In someembodiments, the nanovesicles comprise compressibles (e.g., gas, air).

In some embodiments, the implant comprises a second appendage couplingthe balloon to the first bone of the joint. In some embodiments, theimplant comprises a second appendage coupling the balloon to at leastone second bone of the joint. In some embodiments, the implant comprisesa second appendage configured to couple at least one of the firstportion, the second portion, and the side portion to at least one of thefirst bone and at least one second bone of the joint. In someembodiments, the first appendage and the second appendage are configuredto provide ligamentary-like support to the first bone and the at leastone second bone of the joint. In some embodiments, the first appendageand the second appendage are configured to provide ligamentary-likesupport to the joint. In some embodiments, the first appendage and thesecond appendage are configured to provide tendon-like support to thefirst bone and the at least one second bone of the joint. In someembodiments, the first appendage and the second appendage are configuredto provide tendon-like support to the joint.

In some embodiments, the implant is configured to fit within a cannulahaving a distal end inner diameter of at most 10 millimeters. In someembodiments, the implant is configured to fit within a cannula having adistal end inner diameter of at most 9 millimeters. In some embodiments,the implant is configured to fit within a cannula having a distal endinner diameter of at most 5 millimeters. In some embodiments, theimplant may be configured to be introduced surgically arthroscopicallyas with the cannula 10 mm in diameter or may be introduced throughminimal invasive surgery via a large conduit and plunger requiring asmall arthrotomy several centimeters in diameter. In some embodimentsroutine open surgical insertion with a larger wound may be necessarydepending on clinical condition, complexity and surgeon choice.

In some embodiments, the implant is configured to fold in order to fitwithin a cannula having a distal end inner diameter of at most 10millimeters. In some embodiments, the implant is configured to fold inorder to fit within a cannula having a distal end inner diameter of atmost 9 millimeters. In some embodiments, the implant is configured tofold in order to fit within a cannula having a distal end inner diameterof at most 5 millimeters.

In some embodiments, the implant is configured to be delivered to ajoint through a cannula having a distal end inner diameter of at most 10millimeters. In some embodiments, the implant is configured to bedelivered to a joint through a cannula having a distal end innerdiameter of at most 9 millimeters. In some embodiments, the implant isconfigured to be delivered to a joint through a cannula having a distalend inner diameter of at most 5 millimeters.

In some embodiments, the implant is configured to fold in order to fitwithin a cannula having a distal end inner diameter of at most 10millimeters. In some embodiments, the implant is configured to fold inorder to fit within a cannula having a distal end inner diameter of atmost 9 millimeters. In some embodiments, the implant is configured todeliver by dissolution of the implant material. In some embodiments, theimplant is configured to deliver by release through pores of theimplant. In some embodiments, the implant is configured to deliver byrelease through spaces of the implant. In some embodiments, the implantis configured to deliver by release through nanovesicles of the implant.In some embodiments, the implant is configured to deliver by fracture ofa vacuole by a catalyst such as ultrasound or pressure or otherfracturing catalyst. In some embodiments the release of contents may beover time as a function of normal cumulative limb use forces.

In some embodiments, the implant is configured to at least one of: padcartilage, cushion the joint, deliver a pharmacologic substance, removenoxious enzymes, debride upon implantation, debride the joint followingimplantation, deliver a therapeutic substance, deliver a biologicsubstance, and deliver living stem cells. In some embodiments, theimplant is configured to deliver a cell or tissue to a bone orsurrounding tissue. In some embodiments, the cell is at least one of:stem cell, differentiated cell, pluripotent cell, and post-mitotic cell.In some embodiments, the implant is configured to deliver achemotherapeutic agent to a bone or other surrounding tissues. In someembodiments, the implant is configured to deliver an anti-infectiousmedication to a bone or other surrounding tissues. In some embodiments,the implant is configured to deliver at least one of an antibiotic,antifungals, and analgesics agent. In some embodiments, the implant isconfigured to deliver an antibody. In some embodiments the implant isconfigured as a targeting structure for treatment of proximatepathophysiology. In some embodiments, the implant comprises atransmitter or a sensor that can emit or receive actionable instruction.In some embodiments, the implant comprises a sensor, for non-limitingexample: a gauge, camera, fiberoptic, or other meter, to provideinformation of clinical relevance as it relates to proximate tissue. Insome embodiments, the information received from the implant istransferred to the patient to enhance wound healing or other desiredeffects.

In some embodiments, the implant is configured to be selectivelyinflated to realign limbs.

Provided herein is a method comprising: implanting a knee implant asdescribed herein into a subject, wherein the implant reverses arthritisin the subject.

Provided herein is a method comprising: implanting a knee implant asdescribed herein into a knee joint of a subject and treating a componentof the knee joint of the subject with at least one of an allographtissue, an autograph tissue, and an xenograph tissue. In someembodiments, the implanting step is at least one of: prior to thetreating step, simultaneous with the treating step, and following thetreating step.

Provided herein is a method comprising: implanting a knee implant asdescribed herein into a subject, wherein the implant at least one of:restores joint function and controls arthopathies. In some embodiments,the implanting spares existing anatomy.

Provided herein is a method comprising: debriding a femur condyle of aknee joint of a subject, and implanting a knee implant as describedherein into the knee joint of the subject, whereby the implant isconfigured to anneal to the cartilage of the subject. In someembodiments, the debriding is achieved by steam application.

Provided herein is a method comprising implanting a knee implant asdescribed herein into a joint previously treated with a jointreplacement. In some embodiments, the method comprises removing thejoint replacement prior to implanting the knee implant. In someembodiments, the method comprises clearing infectious matter from thejoint and/or surrounding tissues. In some embodiments, the methodcomprises implanting a second implant of any implant described hereinfollowing removing the implant previously implanted in the joint. Insome embodiments, the method comprises replacing the joint of thesubject following removing the implant previously implanted in thejoint. In some embodiments, the method comprises debriding the bone ofthe joint, and implanting an implant of any implant described herein. Insome embodiments, the method comprises repeating the debriding andimplanting steps.

In some embodiments, the implant is delivered non-arthroscopicallythrough an incision that is at least 1 centimeter long. In someembodiments, the implant is delivered through an incision that is overabout 10 centimeters long. In some embodiments, the implant is deliveredthrough an incision that is at up to about 40 centimeters long.

In some embodiments, the implant replaces periosteum.

In some embodiments, the resilient implant embodying features of theinvention has a first wall configured to be secured to a first bone ofthe joint structure by one or more appendages such as a skirt or one ormore tabs and a second wall configured to engage a second and usuallyopposing bone of the joint structure. A side wall extends between thefirst and second walls of the implant and together with the first andsecond walls preferably defines at least in part an inner chamber orspace between the first and second walls. The implant is configured toprovide linear or curvilinear and/or rotational motion between the firstand second bones which mimics or approximates the natural motion betweenthese bones. The inner chamber or space is configured to maintain afiller material therein such as an inflation fluid or a resilientmaterial and preferably to maintain spacing and provide support betweenthe interior of the first and second walls to avoid significant contacttherebetween. The walls of the implant are preferably sealed about theperiphery thereof to maintain the interior chamber in a sealed conditionto avoid loss of inflation fluid or filling media. The side wall orwalls may be formed from the edges or periphery of the first and secondwalls. The properties of the implant walls and the interior arecontrolled to provide the particular resiliency desired for the joint inwhich the implant is to be placed as well as any desired motion betweenthe first and second walls. A conduit may extend from a source ofinflation fluid or other filling medium to the interior of the implantto facilitate expansion of the implant after deployment within thejoint. The inflation fluid may be a gas, a liquid, a gel, a slurry, or afluid that becomes a suitable resilient solid such as a curable polymer.Selection of the inflation or interior filling medium may depend uponthe nature of the joint structure in which the implant is to bedeployed, its anatomy, pathophysiology, and the properties of theimplant material.

There may be several alternative embodiments depending upon the site inwhich the implant is to be deployed. For example, the polymer formingthe side wall may be semi-compliant or elastic and the inflation fluidmay be incompressible (e.g., a liquid). Alternatively, the polymerforming the side wall may be non-compliant (non-elastic) and theinflation fluid or filling medium may be compressible, e.g., a gas or aresilient polymeric foam or sponge-like solid that may have a closedcell structure. The first and second walls of the implant need not havethe same properties as the side wall. For example, parts of the implantsuch as the side wall portion may be compliant and the first and secondwall portions in contact with the bone or other joint structure may benon-compliant. Additionally, the various walls or portions thereof mayalso be reinforced with non-compliant or semi-compliant polymer strands,beads or gel coating such as biologic or polymer latticework. Thethicknesses of the first, second and side walls may be varied toaccommodate for the needs of the joint structure from the standpoint ofstrength, elasticity and wear resistance. Moreover, the walls of theimplant may be provided with joint tissue regeneration agents thatrebuild the joint structure in which the implant is deployed. Theregeneration agent may be incorporated into the wall of the implantprior to delivery or placed between the surface of the implant and thejoint structure which it contacts after delivery. All or part of thewalls of the implant may also be made of a biodegradable polymer, byminimally manipulated autograph, allograph or xenograph tissues, or acombination thereof. The method of surgery may incorporate a progressiveapplication of the implant embodiments depending upon clinical needs.The walls of the implant may serve one or more functions, including butnot limited to filling space, attachment, strengthening, and anyphysiological function.

The implant is preferably formed of suitable biocompatible polymericmaterials, such as Chronoflex (e.g., ChronoFlexAR®, ChronoFlex AL®,ChronoFlec C®), which is a family of thermoplastic polyurethanes basedon a polycarbonate structure (Al, the aliphatic version, Ar, thearomatic version and C, the casting version) available from AdvanSourceBiomaterials, Corp. Other polymers include BIONATE 80, 80A, 90A, 75D,65D, 55D, 55 or 56, BIONATE I, or BIONATE II, which are alsothermoplastic polyurethane polycarbonate copolymers, available from PTGMedical LLC., an affiliate of the Polymer Technology Group located inBerkeley, Calif. Other commercially available polymers include PurSil®(e.g., PurSil® 10, 20, 35, 40 80A, AL-10 75A) which is a thermoplasticsilicone polyether urethane, CarboSil® (e.g., CarboSil® 10 90A, 20 55D,20 80A, 20 90A, 40 90A, 5) which is a thermoplastic siliconepolycarbonate urethane, Elasthane™ (e.g., Elasthane™ 55D, 75D, 80A)which is an aromatic biomedical polymer and Biospan which is a segmentedpolyurethane. These polymers are available as tubing, molded or dippedcomponents, solution, pellets, as a casting and as a cast film for theside and first and second walls. The implant may be formed by casting,blow molding or by joining sheets of polymeric material by adhesives,laser welding and the like. Other methods of forming the implant mayalso be suitable. Example methods include melting beads and compressionmolding. The walls may also be provided with reinforcing strands whichare located on the surface of the walls or incorporated within thewalls. The implant material should be biocompatible, non-toxic, andnon-carcinogenic and should be resistant to particulation.

The present invention provides an improved joint implant which isdesigned to endure variable joint forces and cyclic loads enablingreduced pain and improved function. Depending upon the particular jointinvolved there may be linear or curvilinear motion between the first andsecond walls, rotational motion between the first and second walls orboth linear and curvilinear motion and rotation motion between the firstand second walls. Preferably, a space is maintained between the innersurfaces of the first and second walls to avoid erosion and wear therebetween. The walls may be opposite sides of the same solid.

The resilient arthroplasty implant embodying features of the inventionis preferably deployed as a minimally invasive procedure to deliver theimplant into a prepared space in a preselected joint structure, whereupon it is inflated to create a cushion, to cover damaged or arthriticcartilage and to be employed to deliver stem cells or livingchondrocytes or other tissue regeneration agents. The goal of suchdeployment is to reduce pain and improve function, to reverse arthritis,to fill in osteochondral defects succinctly, thereby avoiding livingwith both dysfunctional and ablative metal/plastic prostheses or thepathophysiologic state necessitating the procedure. The operative planis simple, systematic, and productive of new joint space with regrowthpotential involving joint debridement by routine arthroscopic coblation,electronic chondroplasty methods or steam application, followed byimplantation of the implant. The implant provides three things, namely acovering or patch for the damaged or worn joint surface, an inflatedcushion to pad gait via inflation or compliant polymer as in normalwalking in the lower extremity, and delivery of regenerative cells onthe cartilage remnant surface. The stem cells may be injected as theimplant is being expanded and/or directed into the adjacent hyalinecartilage via an implant coating or perfused cell template.Viscolubricants such as Synvisc or Hyalgan, analgesics such as Lidoderm,anti-inflammatory and/or antibiotic coatings as well as thosestimulating cell growth may accompany the composite external implant.The implant is left in place as long as feasible, at least untilregenerative cells can attach to the adjacent natural joint surface(usually in about 24 hours), or until wound healing (which may take upto 28 days or more depending on the joint structure). Preferably, theimplant is designed stay within the joint structure for years, providinginert padding, cushioning and a new cell source. The implant may be usedin weight bearing and non-weight bearing interfaces. Animal, such as inhorses and dogs, can benefit from usage of the implant following hip andknee injuries. The implant is intended primarily for mammalian use. Inhumans, the implant may be used in any upper or lower extremity jointand temperomandibular joint.

These and other advantages of the invention will become more apparentfrom the following detailed description and the attached exemplarydrawings.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 depicts an embodiment of the knee implant having appendagesincluding holes and tabs extending from a balloon and including slots toaccommodate ligaments of the knee joint.

FIG. 2 depicts an embodiment of the knee implant having appendagesincluding holes and tabs extending from a balloon and including slots toaccommodate ligaments of the knee joint as well as side views of thesame knee implant.

FIG. 3 depicts an embodiment of the knee implant having appendagesincluding holes and tabs extending from a balloon and including slots toaccommodate ligaments of the knee joint as well as side views of thesame knee implant.

FIG. 4A depicts an embodiment of the knee implant having appendagesincluding ten tabs extending from a balloon and including a slot toaccommodate components of the knee joint.

FIG. 4B depicts an embodiment of the knee implant having appendagesincluding eight tabs extending from a balloon and including a slot toaccommodate components of the knee joint.

FIG. 5 depicts an embodiment of the knee implant curved to simulatecurvature about the condyles of a femur, the implant having appendagesextending from an uninflated balloon (not shown) and including slots toaccommodate ligaments of the knee joint.

FIG. 6A depicts a top-down view of an embodiment of the knee implantcurved to simulate curvature about the condyles of a femur, the implanthaving appendages extending from two inflated balloons and includingslots to accommodate components of the knee joint.

FIG. 6B depicts a bottom-up view of an embodiment of the knee implantcurved to simulate curvature about the condyles of a femur, the implanthaving appendages extending from two inflated balloons and includingslots to accommodate components of the knee joint.

FIG. 7 depicts a top-down view of an embodiment of the knee implantcurved to simulate curvature about the condyles of a femur, the implanthaving appendages extending from an inflated balloon and including slotsto accommodate components of the knee joint.

FIG. 8 depicts a side view of an embodiment of the knee implant curvedto simulate curvature about at least one condyle of a femur, the implanthaving appendages extending from an uninflated balloon (not shown).

FIG. 9A depicts a side view of an embodiment of the knee implant curvedabout at least one condyle of a femur, the implant having appendagesextending from an uninflated or minimally inflated balloon.

FIG. 9B depicts a side view of an embodiment of the knee implant curvedabout at least one condyle of a femur, the implant having appendagesextending from an inflated balloon.

FIG. 9C depicts a side view of an embodiment of the knee implant curvedabout at least one condyle of a femur, the implant having appendagesextending from an inflated balloon and having staples or screws couplingthe appendages to the femur.

FIG. 10A depicts a side view of an embodiment of the knee implant curvedabout at least one condyle of a femur, the implant having appendagesextending from an inflated balloon and showing the inflation mediummoved anteriorly toward the patella when the knee joint is flexed. FIG.10B depicts a side view of an embodiment of the knee implant curvedabout at least one condyle of a femur, the implant having appendagesextending from an inflated balloon and having staples or screws or snapsor pins coupling the appendages to the femur and showing the inflationmedium moved anteriorly toward the patella when the knee joint isflexed.

FIG. 11A depicts an embodiment of the unicompartment knee implant curvedto simulate curvature about one condyle of a femur, the implant havingappendages extending from an uninflated balloon (not shown) andincluding tabs and holes which may be used with couplers to couple theimplant to the femur of the knee joint.

FIG. 11B depicts an embodiment of the unicompartment knee implant curvedto simulate curvature about one condyle of a femur, the implant havingappendages extending from an inflated balloon and including tabs andholes which may be used with couplers to couple the implant to the femurof the knee joint.

FIG. 11C depicts a bottom-up view of an embodiment of the unicompartmentknee implant curved to simulate curvature about one condyle of a femur,the implant having appendages extending from an inflated balloon andincluding tabs and holes which may be used with couplers to couple theimplant to the femur of the knee joint.

FIG. 12A depicts a bottom-up view of an embodiment of the unicompartmentknee implant or patch implant, the implant having appendages, extendingfrom a balloon and including holes, which may be used with couplers (notshown) to couple the implant to the femur of the knee joint.

FIG. 12B depicts a bottom-up view of an embodiment of the unicompartmentknee implant or patch implant, the implant having appendages, extendingfrom a balloon and including tabs and a hole which may be used withcouplers (not shown) to couple the implant to the femur of the kneejoint.

FIG. 12C depicts a bottom-up view of an embodiment of the unicompartmentknee implant or patch implant, the implant having appendages, extendingfrom a balloon and including tabs and a hole which may be used withcouplers (not shown) to couple the implant to the femur of the kneejoint.

FIGS. 13A-13D depict multiple views of a staple adapted to couple animplant to a bone of the joint.

FIG. 14 depicts an embodiment of the knee implant having appendagesincluding holes and tabs and including slots to accommodate ligaments ofthe knee joint as well as side views of the same knee implant.

FIGS. 15A, 15B, and 15C show several views of an embodiment of animplant which has no definable chamber, rather the material of theimplant itself provides the cushion to the bones of the joint (atleast).

FIG. 16 depicts a knee implant embodiment that is generally H orV-shaped, having a slot 26 b that is significantly smaller than otherembodiments, and in this embodiment is effectively replaced with a tab10 i at the same location (e.g. 10 i).

FIG. 17 depicts a knee implant embodiment similar to FIG. 16 which showsa posterior view including the location(s) 50 a-50 d where a fillmaterial such as cement may be placed.

FIG. 18 is an anterior-posterior view of an embodiment of the implant 20attached to a knee model.

FIG. 19 depicts an implant 20 which is more squarely cut for interfacewith a femur, for example, which has been cut square such as is done incertain total knee arthroplasty procedures.

FIGS. 20A and 20B depict a knee implant embodiment that is generallyV-shaped or Y-shaped, and in this embodiment the notch 26 b of otherembodiments, or the tab 10 i of other embodiments is effectivelyreplaced with an appendage 4 e at the same location.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to arthroplasty implants andprocedures for a wide variety of joints such as, for example, hips,knees, shoulders, ankles, elbows, wrists, fingers, toes,temporomandibular joints and the like, but for clarity, as well asbrevity, the discussion herein will focus on an implant for a knee jointor hip joint and an implant for replacing the talus bone of a patient'sankle.

Knee interpositional arthroplasty can replace existing total jointmetal/plastic technology. It intends to fill the gap (literally in someembodiments of the implant) in cases where arthroscopic debridementfails to provide cure, since we can only ‘polish arthritis’ and ‘cleanup the joints’ to date. The polymer medically inflatable implants mayphysiologically restore joint function. Padding is provided wherecartilage is damaged, cushioning to both the femoral tibial and patellafemoral joints when narrowed or pathologic. The implant in someembodiments is adapted to deliver cells, autologous (from the patient),allograph (from another member of the same species) or xenograph (fromanother species,) that restore articular surfaces. Since cartilage is animmunologically privileged tissue, the antigens are buried in thecartilage matrix and antibodies do not reject the refurbished surfacecoating.

The gap (or gaps) filled by the balloon or balloons of the implant mayprovide compliance between opposing joint surfaces (the femoral condyleor condyles and tibial plateau). The femur may have some portion (of notall) of the retropatellar rounded facet “V” shape of hyaline, normallyabout 5 mm thick, or it may not have such hyaline when the implant isinserted. The tibial plateau may have some portion of meniscalfibrocartilages, including all of said fibrocartilages, none of saidfibrocartilages, or some portion thereof. When the knee is extended(straight) the implant buffers the femoro-tibial joint. When the knee isflexed, the implant balloon apposition is more between the trochleargroove portion of the anterior distal femur (groove between the condyleson the ‘front of the knee’) and the patella.

The knee anatomy is unique to other joint anatomies and thus has aunique set of challenges that are addressed by the implant embodimentsdescribed herein. For example, the knee is not a ball and socket jointlike a hip; it is a combination of two joints—the femoral-tibial jointand the patellar-femoral joint. The bones of the knee have facets andirregularities that must be accommodated by a conformable implantdirected to the particular shapes of the bones without impeding thejoints' functions and movements, and/or which minimizes impedance tosuch function and movement. Not only do the joints of the knee worktogether to allow extension and flexion of the knee, but the joints ofthe knee are also designed to allow rotational movement in a screw-likemanner. That is, as the tibia is twisted relative to the femur, thejoints are uniquely designed to allow this twist, but to limit the twistas well. Furthermore, the knee joints are able to withstand forces thatvary depending on the particular movement of the individual, not only inforce strength, but in direction as well. Thus, the implants asdescribed herein are uniquely designed to account for these factors andresult in a knee having preserved natural tissues as well as preservedfunction and movement as compared to typical arthroplasty procedures(such as partial or full knee replacements).

As described herein, embodiments of the implant conform to the patient'sown joint features not only in that it can be pre-molded and/or adaptedto couple to the contours of the patient's bone (condyle, etc), but inthat it has a balloon having an inflation medium that is conformable tothe joint anatomy and allow freedom of joint movement much like naturaljoint while preserving the joint and bone natural tissues as much aspossible. With the ability to fill various chambers of the balloon withvarying materials, and to add rigid and/or semi-rigid pieces to theimplant, the implant can additionally have leveling capabilities andalignment capabilities.

Diagnoses:

Patients may complain of pain and knee joint dysfunction signaled bylocking, clicking, or giving way. Knees may be swollen, malaligned orshow crepitus (palpable crunching on movement.) Instability of ligamentswhether anterior/posterior cruciates, or medial/lateral condyles, aretreated by techniques separate for those entities via allowance forhealing (as for collaterals) or via cruciate repair or reconstruction.

Indications for use of implants provided herein may be those patientsrecognizing greater than or equal to 2 Sq cm of 3-4+/4 traumaticarthritis (ala Carticel). In such cases, the cartilage defect is oftenprecisely locally symptomatic, with point tenderness, clicking if aloose cartilage flap exists, and may be visible on MRI and/orarthroscopic inspection and/or through palpation. The implants usedherein may additionally and/or alternatively be appropriate whenexisting techniques such as ‘picking’, K wire drills, and/or allographimplants fail.

Patients with knee problems typically complain of pain and dysfunction.Pathognomonic symptoms for meniscal tearing include locking, clicking,giving way from wear or twisting the knee. Aching diffusely may arisefrom arthritis or synovitis; anterior knee pain is generallypatella-femoral, increased with stair use due to magnified body weightforces. Diagnosis should be accurate as distinguished from pain throughthe knee actually arising in the back caused by L4 nerve rootirritation. Physical Exam findings of pathologic knees include observedswelling, redness, or deformity. Palpation often aids focus on whichcompartments are involved. The patella inhibition test position connotesretropatellar pathology, and often tracking problems that warrant softtissue or boney correct. Improved limb alignment may increase benefits,and can in part accrue from selective inflation of embodiments of theimplants provided herein. X-rays of the knee are best evaluated inweight bearing views, and should be coupled with other data includingMRI or CT. Relative compartment narrowing suggests cartilagedegradation. Once an embodiment of an implant described herein has beensuccessfully implanted and the knee adequately rehabilitated, theappearance of a knee with such implant should resemble a normal jointX-ray. Knee distension is from saline and/or air insufflation. Kneeimplant patients will benefit from tailored rehab programs, cautiousweight bearing, early motion, and potential the use of constant passivemotion machine regimens.

General Features

Implant Aspects

Provided herein is a resilient implant for implantation into human oranimal joints to act as a cushion allowing for renewed joint motion. Theimplant may endure variable joint forces and cyclic loads while reducingpain and improving function after injury or disease to repair,reconstruct, and regenerate joint integrity. The implant may be deployedin a prepared debrided joint space, secured to at least one of the jointbones and expanded in the space, molding to surrounding structures withsufficient stability to avoid extrusion or dislocation. The implant mayhave has opposing walls that move in varied directions, and an innerspace filled with suitable filler to accommodate motions which mimic orapproximate normal joint motion. The implant may pad the damaged jointsurfaces, restores cushioning immediately and may be employed to restorecartilage to normal by delivering regenerative cells.

The implant may be have no inflation chamber (inner space). The implantmay comprise a chamber which is not inflated once implanted. The implantmay have varying thicknesses at different locations. The implant mayhave different features at different locations. Inflation may involvesingular balloons for cushioning or realignment, multiple separate orconnected vesicles, or small vacuoles that contain gas, fluid, gel,fluid that becomes solid, or combinations thereof. Inflation may beinvoked on either both surfaces of the implant or any surface of theimplant inside or between variable walls (which can be considered layersin certain embodiments). Cushioning while intending to addressdeficiencies in cartilage may accrue from inflation or the use ofcompliant materials without inflation (and without a balloon per se forthat matter) or both.

Provided herein is a resilient interpositional arthroplasty implant forapplication into knee joints to pad cartilage defects, cushion joints,and replace or restore the articular surface, preserving jointintegrity, reducing pain and improving function. The implant may endurevariable knee joint compressive and shear forces, and millions of cyclicloads, after injury or disease requires intervention. The implant mayrepair, reconstruct, and regenerate knee joint anatomy in a minimallymorbid fashion, with physiologic solutions that improve upon the rigidexisting joint replacement alternatives of plastic and metal. In caseswhere cells have been used for joint resurfacing requiring massiveperiosteal harvesting for containment, the polymer walls of someembodiments of the implant can capture, distribute and hold living cellsuntil aggregation and hyaline cartilage regrowth occurs. The implant maybe deployed into a prepared debrided knee joint space, molding andconforming to surrounding structures with sufficient stability to avoidextrusion or dislocation. Appendages (or tabs) of the implant may serveto repair or reconstruct tendons or ligaments. The implant may haveopposing walls that move in varied directions, and an inner space,singular or divided, filled with suitable gas, liquid, and/or complexpolymer layers as force-absorbing mobile constituents, such than robustvalid and reliable joint motion is enabled. There may be no definedinner chamber, however at a particular location in the device theimplant may have different features to aid in cushion, therapeuticeffect, wear resistance, defect correction, or the like.

Provided herein is a resilient orthopedic implant configured fordeployment between a first bone and at least one second bone of a joint.In the case of a knee joint, the first bone may be a femur, a tibia, ora patella. In the case of a knee joint, the second bone may be a tibia,a patella or a femur. The implant may further comprise a ballooncomprising a first portion that is configured to engage the first boneof the joint, a second portion that is configured to engage the secondbone of the joint, a side portion connecting the first portion and thesecond portion, in which the side portion facilitates relative motionbetween the first portion and the second portion, and an interior thatis optionally inflatable with a first inflation medium; and a firstappendage configured to couple the balloon to the first bone of thejoint. The terms “balloon” and “bladder” may be used interchangeablythroughout this disclosure to describe an implant having the featuresdescribed herein.

In some embodiments, at least two of the first portion, the secondportion, and the side portion are contiguous. In some embodiments, thefirst portion comprises a first wall, the second portion comprises asecond wall, and the side portion comprises a side wall. As used herein,each of the terms the “first portion”, the “second portion”, and the“side portion” is used to describe a part of the balloon, and may not beseparate parts in some embodiments. In embodiments wherein no inflationis used, a first portion may be one side and the second portion anotherside of the same implant. In some embodiments, each portion or wall isnamed in order to indicate the general geometry and location of eachportion relative to the other of the portions and/or relative to bonesand/or ligaments and/or tendons of the joint. Likewise, as used herein,each of the terms the “first wall”, the “second wall”, and the “sidewall” is used to describe a part of the balloon or cushioning implant,and may not be separate parts of the balloon in some embodiments.Rather, in some embodiments, each of the walls is named in order toindicate the general geometry and location of each portion relative tothe other of the portions and/or relative to bones and/or ligamentsand/or tendons of the joint. In some embodiments, at least two of firstwall, the second wall, and the side wall are contiguous. Nevertheless,each of the walls may, in some embodiments, be separate parts of theimplant that are joined to form the implant. Likewise, each of theportions may, indeed, in some embodiments, be separate parts of theimplant that are joined to form the implant. In some embodiments, onewall may become the second wall with body movement changing the anatomyof the implant as it related to joint motion.

In some embodiments, the first portion is a term used interchangeablywith the first wall. In some embodiments, the second portion is a termused interchangeably with the second wall. In some embodiments, the sideportion is a term used interchangeably with the side wall. In someembodiments, a wall (whether a first wall, a second wall, and/or a sidewall) of the implant may comprise a plurality of layers. The wall maycomprise multiple materials to impart physical and/or therapeuticcharacteristics to the wall. In some embodiments, a side wall may becomea first or second wall as the implant changes shape through theapplication of joint forces.

The distinction between the first wall and the second wall may merely benoted to show relative location, and may be a contiguous wall that has afirst side (wall) and a second side (wall) where the first side isadapted to contact the first bone, and the second side is adapted tocontact the second bone. The walls may be touching or be made of thesame materials, or they may be made of different materials, or they mayhave additional materials therebetween, such as microstructures,vacuoles, therapeutic agents, padding materials, gels, liquids, solidmaterials, rigid or semi-rigid materials, meshes, foams, honeycombedmaterials, capsules, urethanes, human tissues or media, soft tissues, orthe like, as described herein. Either of the walls themselves may bemade of any of these materials and/or have any of these features. Forexample, a single sheet of BIONATE (e.g., BIONATE I, BIONATE II, BIONATE55D, BIONATE 65D, BIONATE 75D, BIONATE 80, BIONATE 80A, BIONATE 90A) maybe deemed to have a first wall that contacts the first bone, and secondwall that contacts the second bone. In another example, a single sheetof Chronoflex (e.g., ChronoFlexAR®, ChronoFlex AL®, ChronoFlec C®) maybe deemed to have a first wall that contacts the first bone, and secondwall that contacts the second bone. Nevertheless, the single sheet maybe contiguous, having no particular separation between the walls thatmay be deemed a chamber or balloon. Again, each of the first wall andthe second wall may be, in certain embodiments, so designated only todepict relative location—i.e. in relation to the bone each wall isadapted to contact. The first wall may be so designated in order toindicate an intent that the first wall is in a position to contact thefirst bone, whereas the second wall may be so designated in order toindicate an intent that the second wall is in a position to contact thesecond bone, but the first wall and the second wall may be part of acontiguous implant, without any chamber or balloon therebetween.

The implant walls (first wall and/or second wall, and/or side wall maycomprise a compliant material, and there may not be a separation betweenany of the walls of the implant which could be deemed a chamber. Thematerial of the wall itself may be compliant such that the materialitself accommodates cartilage irregularity and improved alignment of thejoint bodies (ligaments, bones, tissue, etc.).

In some embodiments, the implant comprises a sheet. The sheet may besolid (e.g. comprising polyurethane or another biocompatible material),complex (e.g. comprising Dyneema mesh), or with at least one chamber ofany size from a micrometer, to larger chambers as depicted and describedelsewhere herein. The implant may comprise Dyneema mesh. The implant maycomprise Dyneema fiber. In some instances, the implant comprises DyneemaPurity®. The implant may comprise a fiber. The implant may comprise apolyethylene fiber. The implant may comprise a mesh. The mesh may be arandom structure or a repeating structure (such as a honeycomb). Themesh may comprise a polymer structure of interwoven or randomlyinterlinked fibers or a combination thereof. The mesh may comprise ametal structure of interwoven or randomly interlinked metal fibers or acombination thereof. The mesh may comprise a memory metal (e.g. Nitinolor another memory metal). The mesh may comprise a memory polymer. Themesh may aid in fixing the implant in place. The mesh may be adapted toadd cushion to the bones of joint. The mesh may be adapted to adddurability to implant upon cyclic loading. The mesh may be adapted toadd padding to the bones of joint. The mesh may be filled in itsinterstices with a softer (in durometer) polymer or other material(softer than the material of the mesh itself). The mesh may be filled inits interstices with a softer (in durometer) polymer or other material(softer than the material of the mesh itself). The interstices of themesh may comprise a pharmacologic or therapeutic agent (or both) asnoted herein. The mesh may be filled with a harder material, or amaterial that becomes harder, such as methyl methacrylate. The mesh maycomprise a biodegradable material. In some instances, the mesh does notcomprise a biodegradable material. The mesh may comprise a steel wool.Alternatively, the mesh comprises DNA strands. In some embodiments, themesh comprises intertwined DNA strands. In some embodiments, the mesh isconfigured to wrap a joint end.

In some embodiments there is no chamber in the implant. In such anembodiment, the implant may have a single composition throughout theimplant, and shaped as noted herein with attachment features as notedherein. In such embodiments, distinction between the first wall and thesecond wall may be noted to indicate relative location, and may be acontiguous wall that has a first side (wall) and a second side (wall)where the first side is adapted to contact the first bone, and thesecond side is adapted to contact the second bone. In other embodimentsof the implant, the implant comprises no chamber, however it comprisesvarious regions which have different features than other regions—such ascomprising a mesh between the first wall and the second wall (as notedabove), a cushion between the first wall and the second wall, and/orcomprising any aspects of the fill materials noted in the inflationmediums noted elsewhere herein, but not necessarily provided in achamber which is filled following implantation or at the time ofimplantation. Rather, these aspects may be built into the implant duringimplant manufacture, by layering or other manufacturing processes, andnot necessarily by filling a chamber. In some embodiments, there aremultiple regions having different characteristics—cushioning, sometherapeutic agent delivery, defect correction, padding, for non-limitingexample, or some combination thereof. In some embodiments, the implantachieves these aspects by varying thickness of one of the walls at aparticular region of the implant, for non-limiting example, atload-bearing locations. In some embodiments, the implant is inflatablehaving large chamber (in the 1-100 cm range), or small chamber (in the 1micrometer to 1 cm range). In some embodiments, the implant may comprisesuch a chamber (or chambers) but not involve any inflation. In someembodiments, the implant may not have any inflatable chamber (orchambers) whatsoever. The range of inflation can be consistent with acontinuum whereas implant spacing or vacuous interspace can vary at amolecular level as allowing for macromolecular sizes or macrodendriticmolecules. The molecules covering the exposed or integral implant makeupmay be constructed with coatings or without, that may be suspended ingas, liquid, gel, or solids with vacuoles, bubbles, balloons or bladdersof a size producing a foam or trabecular framework or honeycomb that has‘inflation’ not visually obvious. When encapsulating the cushioning gasor fluid in small containers, the cushioning effect may become moreeffective, and for a given amount of cushioning the intercell pressurecan be reduced. The implant may comprise a foam between the first walland the second wall. The implant may comprise a microvoid (i.e. a voidin the implant material that is in the 1 micrometer to 1 mm size range).The implant may comprise first wall or second wall that may beprefabricated containing compressible material into which substances maybe introduced via needle injection or cannula. The compressible materialmay be a gas or a foam mixed with a liquid. The implant may comprisefirst wall or second wall that may be prefabricated containingdisplaceable material into which substances may be introduced via needleinjection or cannula. The displaceable material may be a gas or liquid.

In some embodiments, the implant comprises a selectively inflatablechamber that may pad a uniquely damaged and/or collapsed joint region,thus restoring both protective cushioning and adjacent limb alignment asthat otherwise accomplished (for example via proximal tibial or distalfemoral osteotomy in the case of a knee implant). A chamber or redundantmembrane may, depending on the embodiment, not be inflated at all. Inother embodiments, the chamber or redundant membrane may be maximallyinflated so as to appear as a diffuse balloon appendage fastened to theotherwise capped and adherent polymer solid joint end wrapping. Thesingular macroscopic cells or inflated polymer segment make take on anyshape conforming to the recipient site defect and/or the inflation depomay have a prefabricated shape planned to accommodate a certain amountof infusion whether as an extension into the knee joint as a flattenedbladder mimically meniscal fibrocartilage or topping off a femoral headanalogous to the external radius of a bipolar hip hemiarthroplasty. Ineither or any case the natural polymer pliability and ability toelastically deform may match the normal joint motions physiologically.

The implant may comprise materials without obvious or definableinflation of any sort, producing a cushioning effect usually over oneprimary joint surface but potentially over multiple, providing a usefulcushioning via polymers of variable albeit solid material nature andreasoned compliance. In certain embodiments, the implant material per seand/or inflational enlargement immediately or gradually comes to conformto, accommodate, adjust and fill the indentations or defects on the sideof implant in apposition to the defect. A semi-fluid tendency of certainembodiments permits both immediate post insertional and delayed jointsurface alignment adjustments that may be increased by injection orcannular infusion, or deceased by aspiration or valvular evacuation.

In some embodiments, the filling material is an inflation medium. Thefirst wall is secured to the end of the first bone by a skirt thatextends from the first wall and the second wall engages the end surfaceof the second bone and may also be secured thereto. In some embodiments,the skirt 18 is called an appendage. The side wall extending between thefirst and second walls and defines at least in part the implant interiorwhich is filled with filling material (or an inflation medium). Theinner surfaces of wall and skirt preferably conform to the particularsurface of the head of the patient's first bone. In some embodiments,the inner surfaces of wall and skirt preferably conform to theparticular surface of the patient's first bone. The outer surface of thesecond wall is preferably configured to conform to the end surface ofthe second bone. In some embodiments, the outer surface of the secondwall is preferably configured to conform to a surface of the secondbone.

The edge of the implant may have a depending skirt to secure or anchorthe implant to the end of bone, but may have one or more depending tabs(or appendages) that may be employed for similar functions as will bediscussed in other embodiments. The skirt (and/or tabs, and/orappendages) may tightly fit about the end of the first bone as shown, orthe skirt can be secured by adhesive (e.g. methyl methacrylate, bonein-growth) to the supporting bone structure or be mechanically connectedby staples, screws and the like. Moreover, the lower portion of theskirt may be secured by a purse string suture or a suitable strand(elastic or tied) that is tightly bound about the outside of the skirt.

In some embodiments the implant comprises an in-growth patch on at leastone of the first portion configured to engage the first bone, the secondportion configured to engage the second bone, the side portion, and theappendage. The in-growth patch may be configured to encourage and/orpromote tissue in-growth, such as bone in-growth, for non-limitingexample. The patch may be as large as the portion itself (whether thefirst portion the second portion, the side portion, or the appendage) ormay be smaller than the portion (such as in the shape of a strip orother shaped patch). The in-growth patch may comprise a surfaceirregularity or roughness. The in-growth patch may be Velcro-like. Insome embodiments the implant comprises an in-growth patch on the firstportion and/or the second portion, from (and in some embodimentsincluding) a first appendage to a second appendage. In some embodiments,wherein the appendages loosen from attachment from the bone (by designand/or from wear and/or over time), the in-growth patch aids in securingthe implant to the bone. In some embodiments, the in-growth patchcomprises beads and/or bead-like elements attached to the implant. Suchan in-growth patch may be configured to simulate trabecular bone spaceof a normally cancellous latticework. In some embodiments, the beads aresintered beads of various sizes. In some embodiments, the beads aresintered beads about 400 microns in size. With respect to bead size, theterm “about” can mean ranges of 1%, 5%, 10%, 25%, or 50%. In someembodiments, the first bone and/or the second bone is roughened toacquire a bleeding bone to facilitate in-growth. In some embodiments,about 0.5 mm of cortical tissue is removed to facilitate in-growth.

In some embodiments, the appendage of the implant comprises a hook. Insome embodiments the hook is angled. The hook may comprise a piece ofmetal sandwiched between two polymer pieces. The hook may comprise apiece of metal encased in polymer. In some embodiments, the hook maycomprise a piece of metal and a portion of the metal piece may beencased in polymer. In some embodiments, the hook may comprise a pieceof metal and a portion of the metal piece may be sandwiched between twopolymer pieces. The metal of the hook may reinforce the appendage tabsfor securing the implant to the bone of the joint. In some embodiments,the metal of the hook is formed of a 1 centimeter by 1 centimeter metalpiece. The metal of the hook, or a portion thereof, may protrude fromthe appendage. The metal may be bent toward the bone to which it isconfigured to attach. The metal may be bent at about a 270 degree angle(as compared to the non-bent portion of the metal, or as compared to therest of the appendage, for non-limiting example). The term about whenreferring to angle of bend of the metal of the hook can mean variationsof 1%, 5%, 10%, 20%, and/or 25%, or variations of 1 degree, 5 degrees,10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, 40 degrees,45 degrees, and/or up to 90 degrees. In some embodiments, the bone maybe prepared to receive the hook, such as by a hole or slot into whichthe hook (or a portion thereof) is placed. In some embodiments, the boneis not prepared in advance to receive the hook, and the hook mayself-seat into the bone by pressure applied to the hook into the bone.In some embodiments, the implant may comprise multiple appendages, and aplurality of the appendages has hooks. In some embodiment the implantmay be screwed on or snapped on or secured with a combination ofelements, such as stabilizers and sutures.

In some embodiments, the implant comprises a second appendage couplingthe balloon to the first bone of the joint. In some embodiments, theimplant comprises a second appendage coupling the balloon to at leastone second bone of the joint. In some embodiments, the implant comprisesa second appendage configured to couple at least one of the firstportion, the second portion, and the side portion to at least one of thefirst bone and at least one second bone of the joint. In someembodiments, the first appendage and the second appendage are configuredto provide ligamentary-like support to the first bone and the at leastone second bone of the joint. In some embodiments, the first appendageand the second appendage are configured to provide ligamentary-likesupport to the joint. In some embodiments, the first appendage and thesecond appendage are configured to provide tendon-like support to thefirst bone and the at least one second bone of the joint. In someembodiments, the first appendage and the second appendage are configuredto provide tendon-like support to the joint.

In some embodiments, the implant comprises an inflation port incommunication with the interior of the balloon for inflation of theinterior of the balloon with the first inflation medium. In someembodiments, the balloon is punctured to inflate the interior of theballoon with the first inflation medium. In some embodiments, theballoon is self-sealing. In some embodiments, the balloon isself-sealing upon inflation of the interior of the balloon with thefirst inflation medium. In some embodiments, the implant comprises aseal capable of closing the interior of the balloon. In someembodiments, a series or collection of balloons as bubblewrap areadjacent to each other or in a series such that they share or distributeforces across joints or with weight bearing. In some embodiments thecontents from one balloon may transfer to another balloon or the size ofone balloon may change in relation to adjacent balloons as with shoesthat contain air soled subject to roving forces.

The implant interior, if existing depending on the embodiment, betweenthe walls and the wall may be filled with filler material (or aninflation medium) which aids in maintaining the desired implant dynamicswithin the joint structure. The nature of the filler material such as afluid and the characteristics of the walls may be selected to maintain adesired spacing between the walls in order to accommodate the pressureapplied by the bones of the joint structure to the implant and to allowsuitable motion between the first and second walls of the implant whichfacilitate bone motion which mimics or approximates normal movement forthe joint members involved. Alternatively, as mentioned above, the innerchamber may be filled with resilient material to provide the desiredspacing, pressure accommodation, while allowing desired physiologicmotion between implant layers. The implant is preferably configured tobe shaped like the joint space and bone surfaces being replaced or tofill the void produced by injury or disease so that the natural jointspacing and cushioning of the joint interface is restored toward normalphysiologic appearance and function. Fluids such as saline, mineral oiland the like may be employed to inflate the implant. In someembodiments, the inflated space can be maintained in the expandedposition not by the contents (e.g. gas) but rather by the trabecularframework that props the walls apart, like cancellous bone fills thespace between cortices with microscopic cavities that can be filled withvarious mediums. Such spaces may change with pathology such as bone withosteoporosis or lungs with emphysema. Therapeutic or physiologic fillerthat may be introduced into the implant, and transferred into the bodythrough varied mechanisms, many of which are described elsewhere hereinor would be known to one of skill in the art.

In some embodiments the implant may comprise vacuoles of pharmacologicsubstances. The vacuoles may be on a bone-engaging portion of theimplant. In some embodiments, the implant comprises bubbles comprisingan active substance such as a pharmacologic substance or other activesubstance. The implant may deliver by dissolution of the implantmaterial (i.e. a biodegradable polymer which releases the activesubstance), and/or by release through pores of the implant (wherein thepolymer is permeable to the active substance), and/or by fracture of thevacuole (or bubble, or space) by a catalyst such as ultrasound orpressure or other fracturing catalyst. The implant may deliver theactive substance at a time after the actual implanting of the implantinto the joint, for example an hour later, less than a day later, a daylater, less than a week later, a week later, less than a month later,and/or a month later. In some embodiments, stem cells that arepercolating in the bubble (or vacuole, or space) may be delivered to thejoint space (or a constituent of the joint) after the implant isinserted into the joint. Active agents may, for non-limiting example,include cells (e.g., stem cells, differentiated cells, pluripotentcells, post-mitotic cells), growth factors, antibodies, biomolecules,biologics, chemical compounds, antibiotics, and/or viscolubricants. Insome embodiments, the implant may comprise enzyme absorptive‘microscopic sponges’ that could be sucked out or evacuated at or aroundthe time of implant delivery to the joint.

In certain embodiments the implant (or a portion thereof, such as theballoon or balloons) is a weight bearing spacer that allows jointmotions to approach normal, whether filling the space left by anentirely collapsed joint bone or the space of ablated cartilageproximate surfaces diffusely as in osteoarthritis or succinctly as inosteonecrotic defects or localized trauma. The walls of the implant maybe used as a membrane for holding living cells in proximity of theosteochondral defect long enough for the cells to attach (e.g. 24 hours)or to deeply adhere (up to 28 days) or return to normal (up to oneyear). Weight bearing may be expected to increase as distal lowerextremity joints are treated.

Movement (whether linear or curvilinear) between the first and secondwalls of the implant (i.e. of the balloon) as a result of movement ofthe femur and the tibia is illustrated in the comparison between FIGS.9B and 10A, or in the comparison between FIGS. 9C and 10B. In someembodiments, the implant may comprise a balloon that is configured toallow a wall of the implant rolling upon another wall (or the same wall)of the implant (e.g. the side wall rolling upon the first wall, thefirst wall rolling upon the second wall, the second wall rolling uponthe first wall, the first wall rolling upon the side wall, the secondwall rolling upon the side wall, the side wall rolling upon the secondwall, the first wall rolling upon the first wall, the second wallrolling upon the second wall, and/or the side wall rolling upon the sidewall). In some embodiments, the implant may comprise a balloon that isconfigured to allow a portion of the implant rolling upon anotherportion (or the same portion) of the implant (for non-limiting example,the side wall rolling upon an appendage, the first wall rolling upon anappendage, and/or the second wall rolling upon an appendage). In someembodiments, the implant may comprise a balloon that is configured toallow movement of a portion of the implant rolling upon cartilage. Whilenot shown in the drawings, there may be slippage between a portion ofthe implant (whether an appendage, a wall, or some other portion of theimplant) and a joint component (whether a bone, ligament, tendon orother tissue). This slippage may be in addition to wall movements withinthe implant per se to provide desired joint movements. While not shownin the drawings, there may be slippage between the second bone (forexample, the tibia) and the second wall in addition to wall movementswithin the implant per se to provide desired joint movements. Theappendage (or appendages) is (are) designed to secure the implant to thejoint structure so as to avoid dislocation of the implant. Movement ofthe joint with the implant in place may be a shared function of both themoving opposing walls of the implant but also a function of the movementof the wall which may be less attached to the joint members. There maybe slight movement between the appendage, first wall and the first bone.The walls of the balloon may compress and/or stretch to accommodate boneinterface movement. Material choices, material dimensions, and implantdimensions, placement and/or coupling may be chosen to allow for thedesired amount of compression, stretching relative movement of variousjoint and/or implant components. For non-limiting example, the walls ofthe implant may be thicker is some areas to accommodate particular loadsand the side wall may be thinner and more elastic to accommodate rollingand stretching thereof.

The interior of implant may be adjustably filled by the physician froman appropriate source thereof after the implant is deployed to ensurethat the pathologic joint space becomes a resilient cushion again whichaids restoration of worn or damaged cartilage interfaces in the joint bycovering cartilage defects with the implant material, cushioning thejoint and defects therein and delivering cell regeneration agents. Inone embodiment, the arthroplasty implant comprises a bio-compatibleinflatable member that is filled with a biocompatible fill material suchas a gas, liquid, gel or slurry, or fluid that becomes a resilient solidto provide relative movement between the first and second walls. Thefilling or inflation media may be inserted through an injection valvesite leading to the cannula which delivers the material into theinterior of the implant. In an alternative embodiment, the implant maybe filled with or have an interior formed of biologically compatibleresilient material, e.g. a closed cell sponge filled with suitable fluidthat is inserted into the interior of the implant prior to the implant'sdeployment or injected into the interior after the implant is deployedat the joint site. The interior of the implant may be provided withlubricious material to facilitate movement between the inner wallsurfaces and to minimize contact wear therebetween. The polymeric wallsof the implant may be impregnated with or otherwise carry tissueregeneration agents such as stem cells, living chondrocytes, and/orgenes to repair joint surfaces.

Motion is believed to be primarily between the spaced walls (orportions) of the implant peripherally secured to joint structures,although some motion may occur between the implant and the jointsurfaces. As shown in multiple Figures (including, FIGS. 1-7), theimplant may be provided with a slot extending from the periphery of theimplant toward the balloon of the implant to accommodate at least oneligament of the joint. Knee implants may have two slots leading toseparate passages for receiving the anterior and posterior cruciateligaments. Implant walls should have sufficient inherent flexibility tomold to the existing deformities imposed by either natural ligament,bone, tendon or remaining cartilage deformities of the internal jointspace, and thus filled as a cushion. The wall exteriors may be flat orformed with random or specific patterns for purposes of glide or trendsfor traction against adjacent surfaces, or as sulci or venues for celldelivery materials.

The exterior of the implant may have a mesh material with a plurality ofchords (or appendages) for securing the implant to adjacent bones or toremnant ligaments which are attached to adjacent bones. The exterior ofthe implant may comprise Dyneema mesh. The exterior of the implant maycomprise Dyneema fiber. In some instances, the exterior of the implantcomprises Dyneema Purity®. The exterior of the implant may comprise afiber. The exterior of the implant may comprise a polyethylene fiber.

The dimensions of the various implant walls may vary depending upon thematerial properties thereof as well as the needs for a particular joint.Additionally, the first and second walls may require a thicknessdifferent from the side wall. Generally, the implant may have a wallthicknesses of about 0.125 mm to about 3 mm, preferably about 0.5 mm toabout 1.5 mm. The spacing between the first and second wall within theinterior can vary from about 0.5 mm to about 5 mm. Thicknesses of thefixation tabs may be at least one of: about 1 mm, about 2 mm, about 3mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 1 mm to about6 mm, about 2 mm to about 4 mm, 1 mm to 6 mm, and 2 mm to 4 mm, fornon-limiting example. The implant may comprise a reinforcing rim or areinforced tab, which includes a change in tab material to make itstronger, or include a metal rim to reinforce the attachment location.The reinforcement element may be embedded in the tab or in a wall at theperiphery of the implant (for example in instances where the coupler isnot located at a tab per se).

In some embodiments, the implant has a first wall, a second wall, and aside wall which define the implant interior (or exterior) which containsfilling material. In some embodiments, the filling material is aninflation medium. The first wall is secured to the end of the femur byat least one appendage that extends from the first wall and the secondwall engages the end surface of the second bone (which in the case of afemoral-tibial joint implant, would be the tibia) and may also besecured thereto. The side wall extending between the first and secondwalls defines at least in part the implant interior which is filled withfilling material (or an inflation medium). The inner surfaces of walland appendage may conform to the particular surface femur, for exampleby being wider in particular locations and/or longer in particularareas. For example a dual compartment implant (described herein) mayhave a wider section to cover the medial condyle than the lateralcondyle (as shown in FIGS. 1, 2, 3, 6A, 6B, and 7). In another example,the length of the implant the along the external edge may be longer thanthe length of the implant along the trochlear groove edge (as shown inFIGS. 11A, 11B and 11C). In yet another example, the width may varyalong a single condyle, such as is shown in FIGS. 12A-12C, wherein thewider edge of the implant is adapted to fit over at least a portion ofthe anterior condyle, and the narrower portion is adapted to fit over atleast a portion of the posterior condyle. In some embodiments, the innersurfaces of the first wall and appendages preferably conform to theparticular surface of the patient's femur, and do so by not onlydimensions of the implant (lengths, widths, balloon location and shape),but also and/or alternatively due to appendage and/or tab and/or holeand/or coupler location and/or surface contours of the first wall. Theouter surface of the second wall may be configured to conform to the endsurface of the second bone (which may be a tibia or a patella, forexample). In some embodiments, the outer surface of the second wall isconfigured to conform to a surface of the second bone (which may be atibia or a patella, for example). The figures provided herein are highlyschematic and do not depict details of the joint surface features, sincehuman pathology and variation reflects both the patient's immediate andevolving pathophysiology. Neither do the figures depict other jointfeatures such as cartilage, tendons, ligaments and other soft tissuesand fluids of the joint for ease of viewing that which is depicted.

In some embodiments, the implant is configured to resemble the shape ofthe natural hyaline of a normal knee. For example, the normal hyaline istypically “H” shaped, thus certain embodiments of the implant aregenerally “H” shaped. The H may be an exaggerated H form, and thenotches of the H may be extended on one side, while nearly nonexistenton the other side, such as is shown in certain figures, such the “H” maylook more like a “U” or “V” or contain a tab in the notch. For eachjoint the cartilage surface shapes, implant design, and method ofsurgery can vary by adapting to normal anatomy in a particular patient,to expected weight bearing, and use intent.

Implant Materials and Material Features

In some embodiments, the implant comprises polymer. Polymers maycomprise at least one of: a polyurethane (such as, for example,ChronoFlex AR, ChronoFlex AL®, ChronoFlec C®), a polycarbonate urethane,a thermoplastic polycarbonate urethane (such as BIONATE, e.g., BIONATEI, BIONATE II, BIONATE 55D, BIONATE 65D, BIONATE 75D, BIONATE 80A,BIONATE 90A, BIONATE 55 or BIONATE 80), ethylene-vinyl acetatecopolymer, multiblock copolymers of poly(ethylene oxide) (PEO) andpoly(butylene terephthalate) (PBT), PEG, PEO, and a polyetheylene. Insome embodiments the implant comprises a 125 micron thicknessthermoplastic polycarbonate urethane. In some embodiments, thethermoplastic polycarbonate urethane has a low coefficient of friction.In other embodiments, the thickness of walls intends to mimic naturalhyaline cartilage a the involved body location and may be one of: about0.5 mm, about 1 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm,about 4 mm, 0.5 mm, 1 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 1 mm-6 mm, 1mm-4 mm, and 1 mm-3 mm.

The implant may comprise to a plurality of layers of polymer (such asChronoFlex AR, ChronoFlexAR®, ChronoFlex AL®), ChronoFlec C®) in asolvent and evaporating the solvent after applying each layer. In someembodiments, the implant comprises a polyurethane that is sprayed anddried (wherein the spraying and drying is repeated at least once) to adesired thickness.

In some embodiments, the implant is created by dip molding a mandrelhaving a shape of a bone of the knee joint (the medial condyle, thelateral condyle, the tibia, for non-limiting example) into a polymersolution (for non-limiting example, a urethane polymer such asChronoflex (e.g., ChronoFlexAR®, ChronoFlex AL®), ChronoFlec C®)).Following each dip, the implant is dried for a specified time, which maybe, for example, about 3 seconds, about 4 seconds, about 5 seconds,about 6 seconds, about 7 seconds, about 8 seconds, about 9 seconds,about 10 seconds, about 15 seconds, about 20 seconds, about 25 seconds,about 30 seconds, about 45 seconds, about 1 minute, about 2 minutes,about 5 minutes, about 10 minutes, about 15 minutes, and over about 15minutes. The term “about” used herein in reference to drying time of theimplant can mean variations of at least one of 5%, 10%, 25%, and 50%, Insome embodiments, no drying step is used. The dipping may be repeatedmultiple times. In some embodiments a single dip is sufficient. In someembodiments, the dipping is repeated 2 times. In some embodiments, thedipping is repeated 3 times. In some embodiments, the dipping isrepeated 4 times. In some embodiments, the dipping is repeated 5 times.In some embodiments, the dipping is repeated 6 times. In someembodiments, the dipping is repeated 7 times. In some embodiments, thedipping is repeated 8 times. In some embodiments, the dipping isrepeated 9 times. In some embodiments, the dipping is repeated 10 times.In some embodiments, the dipping is repeated 11 times. In someembodiments, the dipping is repeated 12 times. In some embodiments, thedipping is repeated 13 times. In some embodiments, the dipping isrepeated 14 times. In some embodiments, the dipping is repeated 15times. In some embodiments, the dipping is repeated 16 times. In someembodiments, the dipping is repeated 17 times. In some embodiments, thedipping is repeated 18 times. In some embodiments, the dipping isrepeated 19 times. In some embodiments, the dipping is repeated 20times. In some embodiments, the dipping is repeated 21 times. In someembodiments, the dipping is repeated 22 times. In some embodiments, thedipping is repeated 23 times. In some embodiments, the dipping isrepeated 24 times. In some embodiments, the dipping is repeated 25times. In some embodiments, the dipping is repeated over 25 times. Insome embodiments, the dipping is repeated a sufficient number of timesto create an implant that is a prescribed thickness. The thickness mayvary depending on the polymer and depending on the embodiment of theimplant. The thickness may be at least one of: about 25 microns thick,about 50 microns thick, about 100 microns thick, about 125 micronsthick, about 150 microns thick, about 200 microns thick, about 250microns thick, about 300 microns thick, about 350 microns thick, about400 microns thick, about 25-50 microns thick, about 50-100 micronsthick, about 50-200 microns thick, about 100-150 microns thick, about150-300 microns thick, about 100-300 microns thick, about 100-500microns thick, about 200-500 microns thick, and about 200-1000 micronsthick. The term “about” used herein in reference to thickness of theimplant can mean variations of at least one of 5%, 10%, 25%, and 50%,The thickness may vary at different locations of the implant. In someembodiments, the implant is fabricated in two pieces, one or more ofwhich is molded to form an interior when the two pieces are puttogether. In some embodiments, the implant is filled by puncturing theimplant wall and sealing the puncture hole with a plug, patch or othersealant. The plug, patch, or other sealant may comprise Chronoflexmaterial (e.g., ChronoFlexAR®, ChronoFlex AL®, ChronoFlec C®), fornon-limiting example. The plug, patch, or other sealant may comprise thesame material from which the implant is constructed, for non-limitingexample. In some embodiments, the implant thickness may be manymillimeters, for example, where larger defects or malignments are beingcorrected.

The walls of the implant embodying features of the invention may becomposite structures. For example, the innermost layer may be imperviousto preclude escape of inflation or other filling media, a central layermay be porous or otherwise contain treatment or cell regenerationagents, and the outer layer may be a thin, but strong layer of athermoplastic, such as a thermoplastic polyurethane for non-limitingexample, which has microporosity sufficient to allow passage or egressof treatment or cell regeneration agents from the central layer (orsecond layer). The degree of microporosity to enable egress of treatmentor cell regeneration agents from the central layer is found in polymerlayers such as Chronoflex (e.g., ChronoFlexAR®, ChronoFlex AL®,ChronoFlec C®) or BIONATE (e.g., BIONATE I, BIONATE II, BIONATE 55D,BIONATE 65D, BIONATE 75D, BIONATE 80A, BIONATE 90A, BIONATE 55 orBIONATE 80).

The external wall (and/or the bone engaging surface) of the implant maybe coated and/or impregnated with a latticework of polymer that issurface sprayed or layered on the outside (or bone engaging surface) ofthe implant to promote cartilage tissue regeneration. This most externalsurface coating may contain living chondrocytes (for example, as isprovided in the Carticel procedure by the Genzyme company), and/or maycontain stem cells with directed gene mutations to enhance adherence ofthe coating to the implant. Chondrocytes from companies such as Tygenixor Histogenics may be used for greater aggregation potential. The boneengaging surface may comprise peaks and troughs. The living cells may beimposed in between (and/or provided in the) troughs of the implantsurface while the surface areas of prominence (the peaks of the surface)may be used for at least one of: space validation, traction, and cellprotection.

The implant may be formed of suitable bioabsorbable materials so thatthe implant may be absorbed within a particular predetermined timeframe. Suitable bioabsorbable materials include polylactic acid,polyglycolic acid, polycaprolactone, copolymers, blends and variantsthereof. Suitable bioabsorbable materials may also/alternatively includepoly(hydroxyalkanoate)s of the PHB-PHV class, additional poly(ester)s,and natural polymers, particularly, modified poly(saccharide)s, e.g.,starch, cellulose, and chitosan. The walls of the implant may be (inwhole and/or in part) bioabsorbable. The balloon may be (in whole and/orin part) bioabsorbable. As used herein the terms bioabsorbable,bioerodable, and/or bioabsorbable may be used interchangeably. The wallsof the implant may release a pharmaceutical agent or an biological agent(such as stem cells, differentiated cells, pluripotent cells,post-mitotic cells, living chondrocytes, gene therapies, and the like).The release of such agents (whether biological or pharmaceutical, or acombination thereof) may occur over time, as the wall of the implant (oras the balloon) bioabsorbs in some embodiments, or as the joint is used(i.e. through pressure, for non-limiting example). In some embodiments,at least one of the implant walls is permeable to a pharmaceutical agentand/or a biological agent, such as in an embodiment wherein theinflation medium comprises the pharmaceutical agent and/or biologicalagent. In some embodiments, at least one of the implant walls has poresthrough which the pharmaceutical agent and/or the biological agent mayfit, such as in an embodiment wherein the inflation medium comprises thepharmaceutical agent and/or biological agent. In some embodiments thecontents may contain targeting drugs such as gleevac that turn off tumormolecules as those in GIST. Cell-specific drugs targeting tumors bydesign may require nano-sized micelles with hydrophilic shells toprotect core agents. In some embodiment hydrogels are used and tailoredto swell thus releasing trapped molecules or cells through weblikesurfaces, controlled by internal or external triggers such as ph,magnetic fields, or temperature. Dendritic macromolecules may be used inimplants to deliver agents en masse deploying a controllable size andstructure. In some embodiments, individual agent molecules or hubs maybe incorporated via covalent bonds.

In some embodiments, the interior comprises a plurality of inflatablechambers. In some embodiments, the interior comprises a plurality ofindividually inflatable chambers. In some embodiments, a first chamberof the plurality of individually inflatable chambers is adapted to beinflated with the first inflation medium, and a second chamber of theplurality of individually inflatable chambers is adapted to be inflatedwith a second inflation medium. The implant may be provided withlatticework or other reinforcing strands, preferably on the exterior orwithin the wall thereof to control the maximum expansion of the implantwhen deployed at the orthopedic site.

In some embodiments, the implant comprises amniotic membrane (and/or acomponent thereof). In some embodiments, the implant comprises amnioticsac (and/or a component thereof). In some embodiments, the implantcomprises amniotic tissue (and/or a component thereof). Amnioticmembrane (and/or sac and/or tissue) is unique in that its mechanicalproperties include that it slippery on one side (lubricious, low modulusof elasticity) and sticky (adherent) on the other. In some embodiments,at least one of the first wall, the second wall and the side wallcomprise amniotic membrane or a component thereof. In some embodiments,at least one of the first wall, the second wall and the side wallcomprise amniotic sac or a component thereof. In some embodiments, atleast one of the first wall, the second wall and the side wall compriseamniotic tissue or a component thereof. The amniotic membrane and/oramniotic sac and/or amniotic tissue may be used in conjunction withother biologic agents, pharmaceutical agents, and/or therapeutic agents.Amniotic tissue is used extensively in pleuripotential cells. Itqualifies as HTBP (Human Tissue Based Product) because of the short termtime span on the product and origin.

In some embodiments, the balloon is a composite structure. In someembodiments, the balloon comprises layers of porous and/or non-porousmaterials, or otherwise contain treatment or cell regeneration agents.In some embodiments, a first layer of the balloon is a thin, but stronglayer of a thermoplastic, such as a thermoplastic polyurethane, fornon-limiting example, which has microporosity sufficient to allowpassage or egress of treatment or cell regeneration agents from a secondlayer. The second layer may be a central layer (which lies between thefirst layer and a third layer or a fourth layer or more layers). Thefirst layer may comprise a bone engaging surface in some embodiments.The degree of microporosity to enable egress of treatment or cellregeneration agents from the second layer is found in polymer layerssuch as Chronoflex (e.g., ChronoFlexAR®, ChronoFlex AL®, ChronoFlec C®)or BIONATE (e.g., BIONATE I, BIONATE II, BIONATE 55D, BIONATE 65D,BIONATE 75D, BIONATE 80A, BIONATE 90A, BIONATE 55 or BIONATE 80). Thebone engaging surface of the implant may be coated and/or impregnatedwith a latticework of polymer that is surface sprayed or layered on thebone engaging surface of the implant to promote cartilage tissueregeneration. This bone engaging surface coating may contain livingchondrocytes (for example, as is provided in the Carticel procedure bythe Genzyme company), and/or may contain stem cells with directed genemutations to enhance adherence of the coating to the implant. The boneengaging surface may comprise peaks and troughs. The living cells may beprovided in troughs while the surface peaks may be used for at least oneof: space validation, traction, and cell protection.

In some embodiments, the implant is pre-molded to fit about at least onecondyle of the femur. In some embodiments, the implant comprises amemory plastic. In some embodiments, the implant comprises a wire frame.In some embodiments, the wire of the wire frame comprises a memorymetal. In some embodiments, the memory metal comprises nitinol. In someembodiments, the wire frame is disposed in the periphery of the implantor a portion thereof. In some embodiments, the wire frame is configuredto aid in placement against the posterior of the condyle.

In some embodiments, at least a portion of the implant comprises aslippery surface. In some embodiments the slippery surface is configuredto allow for relative movement between the implant (or a portionthereof) that is coupled to the femur and the tibia. In some embodimentsthe slippery surface is configured to allow for relative movementbetween the implant (or a portion thereof) that is coupled to the femurand the patella.

In some embodiments, the implant comprises a sheet. The sheet may besolid (e.g. comprising polyurethane or another biocompatible material),complex (e.g. comprising Dyneema mesh), or with at least one chamber ofany size from a micrometer, to larger chambers as depicted and describedelsewhere herein. The implant may comprise Dyneema mesh. The implant maycomprise Dyneema fiber. In some instances, the implant comprises DyneemaPurity®. The implant may comprise a fiber. The implant may comprise apolyethylene fiber. The implant may comprise a mesh. The mesh may be arandom structure or a repeating structure (such as a honeycomb). Themesh may comprise a polymer structure of interwoven or randomlyinterlinked fibers or a combination thereof. The mesh may comprise ametal structure of interwoven or randomly interlinked metal fibers or acombination thereof. The mesh may comprise a memory metal (e.g. Nitinolor another memory metal). The mesh may comprise a memory polymer. Themesh may aid in fixing the implant in place. The mesh may be adapted toadd cushion to the bones of joint. The mesh may be adapted to adddurability to implant upon cyclic loading. The mesh may be adapted toadd padding to the bones of joint. The mesh may be filled in itsinterstices with a softer (in durometer) polymer or other material(softer than the material of the mesh itself). The mesh may be filled inits interstices with a softer (in durometer) polymer or other material(softer than the material of the mesh itself). The interstices of themesh may comprise a pharmacologic or therapeutic agent (or both) asnoted herein.

To be clear, in some embodiments, there is no chamber in the implant. Insuch an embodiment, the implant may have a single composition throughoutthe implant, and shaped as noted herein with attachment features asnoted herein. In other embodiments of the implant, the implant comprisesno chamber, however it comprises various regions which have differentfeatures than other regions—such as comprising a mesh between the firstwall and the second wall (as noted above), a cushion between the firstwall and the second wall, and/or comprising any aspects of the fillmaterials noted in the inflation mediums noted elsewhere herein, but notnecessarily provided in a chamber which is filled following implantationor at the time of implantation. Rather, these aspects may be built intothe implant during implant manufacture, by layering or othermanufacturing processes, and not necessarily by filling a chamber. Insome embodiments, there are multiple regions having differentcharacteristics—cushioning, some therapeutic agent delivery, defectcorrection, padding, for non-limiting example, or some combinationthereof. In some embodiments, the implant achieves these aspects byvarying thickness of one of the walls at a particular region of theimplant, for non-limiting example, at load-bearing locations.

Inflation Medium and Inflation or Filling of the Implant Interior

In some embodiments, the implant comprises an inflation medium that iscompressible. In some embodiments, the implant comprises an inflationmedium that comprises a viscolubricant. In some embodiments, the implantcomprises an inflation medium that comprises a pharmacologic substance.In some embodiments, the implant comprises an inflation medium thatcomprises an NSAID. In some embodiments, the implant comprises aninflation medium that comprises chondrocytes. In some embodiments, theimplant comprises an inflation medium that comprises cells (e.g., stemcells, differentiated cells, pluripotent cells, post-mitotic cells). Insome embodiments the implant is configured to anneal the outer mostlayer of the implant (or a portion thereof) to the peripheral ofsuccinct cartilage defects so as to cover them, allowing for healing. Insome embodiments the implant is configured to anneal the outer mostlayer of the implant (or a portion thereof) to the peripheral ofsuccinct cartilage defects so as to cover them, allowing for healingonce new chondrocytes have been installed.

The implant interior (balloon interior) may be inflated with gas. Theimplant interior (balloon interior) may be inflated with liquid. Theimplant interior (balloon interior) may be inflated with saline. Theimplant interior (balloon interior) may be inflated with suspended stemcells. The implant interior (balloon interior) may be inflated with gel.The implant interior (balloon interior) may be inflated with aviscolubricant. The inflation medium in some embodiments stays withinthe balloon, or a portion thereof (as where there are multiple chambersto the balloon). In some embodiments, balloon contents disburse throughmicroporosities and/or dissolving membranes into the joint. In someembodiments, balloon contents disburse by expulsive or evacuationprecipitated through an implant wall after pressure from limb use. Insome embodiments, balloon contents disburse by expulsive or evacuationprecipitated through an implant wall from planned osmosis. In someembodiments, balloon contents disburse by expulsive or evacuationprecipitated through an implant wall from vacuole rupture (whethermechanical rupture, ultrasound, or chemical rupture, for non-limitingexample). In some embodiments, balloon contents disburse by expulsive orevacuation precipitated through an implant wall thereby distributingcontents of the implant interior to joints as lubricious, analgesic,anti-inflammatory and/or otherwise healing substances. In someembodiments, the implant may comprise solid beads or beads containinggel or liquid for sequential disbursement by compressive force throughrupture with varied bead wall thicknesses, or the beads may betime-released (opened) chemically, pharmacologically, or by an outsideultrasound or magnetic force external knee application at appropriateclinical intervals. In some embodiments, the implant may comprisevacuoles containing gel or liquid for sequential disbursement bycompressive force through rupture with varied vacuole wall thicknesses,or the vacuoles may be time-released (opened) chemically,pharmacologically, or by an outside ultrasound or magnetic forceexternal knee application at appropriate clinical intervals. The implantmaterial may be foam or complaint material (such as a compliantpolymer).

The implant interior (or balloon interior) between the first wall andthe second wall is filled with filler material (or an inflation medium)which aids in maintaining the desired implant dynamics within the jointstructure. The nature of the filler material such as a fluid and thecharacteristics of the walls may be selected to maintain a desiredspacing between the walls in order to accommodate the pressure appliedby the bones of the joint structure to the implant and to allow suitablemotion between the first and second walls of the implant whichfacilitate bone motion which mimics or approximates normal movement forthe joint members involved.

Alternatively (and/or additionally), the inner chamber (interior or aportion thereof) may be filled with resilient material to provide thedesired spacing, pressure accommodation, while allowing desiredphysiologic motion between implant layers. The implant may be configuredto be shaped like the joint space and bone surfaces being replaced or tofill the void produced by injury or disease so that the natural jointspacing and cushioning of the joint interface is restored toward normalphysiologic appearance and function. The interior of implant isadjustably filled by the physician from an appropriate source thereofafter the implant is deployed to ensure that the pathologic joint spacebecomes a resilient cushion again which aids restoration of worn ordamaged cartilage interfaces in the joint by covering cartilage defectswith the implant material, cushioning the joint and defects therein anddelivering cell regeneration agents. In one embodiment, the implantcomprises a bio-compatible inflatable member (balloon) that is filledwith a biocompatible fill material (inflation medium) such as a gas,liquid, gel or slurry, or fluid that becomes a resilient solid toprovide relative movement between the first and second walls.

In some embodiments, the features of the implant change over time. Forexample, prior to, at, or during implantation, the implant may comprisea powder methyl methacrylate and a liquid that becomes a slurry uponinsertion or soon thereafter, and that once implanted hardens (or cures)within the implant. The methyl methacrylate (e.g. as a powder) and acatalyst liquid together become solid and are an example of a cement (orbone cement), however other cements or other materials which cure overtime or with heat or with loading or by other methods (chemical orphysical) are contemplated as alternatives. In certain embodiments, atleast one of the powder methyl methacrylate and the liquid is part ofthe implant at the time of implantation. In certain embodiments, atleast one of the powder methyl methacrylate and the liquid is injectedinto or loaded into the implant at the time of implantation or soonthereafter. In certain embodiments, both the powder methyl methacrylateand the liquid are injected into or loaded into the implant at the timeof implantation or soon thereafter. In certain embodiments, at least oneof the powder methyl methacrylate and the liquid is a fill material. Incertain embodiments, the implant does not have a chamber prior toinjection of (or loading of) a fill material between the first wall andthe second wall. The injection (or loading) of a fill material betweenthe first wall and the second wall creates a chamber. In certainembodiments, the implant comprises interstices which are occupied by thefill material. In some embodiments, the methyl methacrylate powder andliquid catalyst are already inside the implant but only mix afterintentional deployment in external or internal manners.

In some embodiments, the first inflation medium imparts rigidity in theimplant. In some embodiments, the first inflation medium imparts cushionin the implant. In some embodiments, the inflation medium chosen for thefirst inflation medium, and/or the particular choice of chamber (inembodiments having multiple chambers) filled with such first inflationmedium aligns the joint. In some embodiments, the inflation mediumchosen for the first inflation medium, and/or the particular choice ofchamber (in embodiments having multiple chambers) filled with such firstinflation medium aligns the bones of the joint. In some embodiments, theinflation medium chosen for the first inflation medium, and/or theparticular choice of chamber (in embodiments having multiple chambers)filled with such first inflation medium changes the bone alignment. Insome embodiments, the inflation medium chosen for the first inflationmedium, and/or the particular choice of chamber (in embodiments havingmultiple chambers) filled with such first inflation medium improvesjoint alignment. In some embodiments, the inflation medium chosen forthe first inflation medium, and/or the particular choice of chamber (inembodiments having multiple chambers) filled with such first inflationmedium restores, at least in part, joint alignment. In some embodiments,individual chambers of the interior may be selectively inflated with afirst inflation medium and/or a second inflation medium. In someembodiments, individual chambers of the interior are selectivelyinflated with a first inflation medium and/or a second inflation mediumin order to reconstruct the joint and/or bones of the joint.

In some embodiments the inflation medium comprises living chondrocytes.

The implant interior (balloon interior) may be inflated with methylmethacrylate as a liquid that becomes a solid or semi-solid (rigid orsemi-rigid). In some embodiments, the inflation medium is a methylmethacrylate or other biocompatible hardening substance which can flowwhen initially put into the chamber, and hardens to become a rigid pieceor semi-rigid piece or solid piece. The methyl methacrylate or otherbiocompatible hardening substance may conform to the shape of thechamber, or may conform to the shape of a space between bones and/orother joint structures. The methyl methacrylate or other biocompatiblehardening substance may conform to a form chosen by the surgeon usingtools and/or pressure to influence the final shape of the rigid pieceformed by the methyl methacrylate or other biocompatible hardeningsubstance upon hardening.

The side wall extends between the first and second walls to form aninterior which receives filling material through tube (also called aconduit herein, or may be called an inflation port). In someembodiments, the inflation port is not a tube, but is a valve which mayor may not extend from a wall of the implant. The valve may be part of awall of the implant, or part of the balloon or a portion thereof. Theimplant would also be appropriate for one condyle of the knee, but othershapes may be desired for other joint configurations whether relativelyflat or more inflated toward a ballooning construct. In someembodiments, the inner diameter of the inflation port (or tube) is 5millimeters maximum. In some embodiments, the inner diameter of theinflation port is about 1 millimeter. In some embodiments, the innerdiameter of the inflation port is about 2 millimeters. In someembodiments, a needle (of typical needle sizes) may be used to inflatethe implant.

A separate portal or tube (not shown) or the existing conduit (tube orvalve), may be used to extract noxious inflammatory enzymes that can beaspirated at appropriate clinical intervals. Inflammatory enzymes in theCOX1, COX2 and or 5LOX pathways can be extracted. Viscolubricants can beinjected into the interior of the resilient arthroplasty implant throughexisting conduit or through a long needle to aide in distension,expansion, lubrication (with predetermined microporosity).

In some embodiments, an inflation medium that generates heat (by meansof a catalyst reaction or other means) may be used to deliver heat to ajoint structure. The heat may aide hyaline cartilage annealing. Thermaleffects of the implant materials are calculated accordingly to benefitand protect the joint surface analogous to a dry suit or wet suit for ascuba diver exposed to temperature extremes. Embodiments of the implantgenerally seek to avoid head from friction via lubricious coatingswhether allograph as amniotic membrane or polymer, for non-limitingexample.

The implant in some embodiments is inserted arthroscopically through acannula about 10 mm in diameter with the implant in the deflatedconstruct, and once inside the prepared joint space and secured thereinby the appendages or tabs, the implant may be distended or inflated withgas, gel, fluid or fluid that becomes a resilient solid to fill theoriginal natural space of a bone of the joint (whether the tibia, femuror patella). Tensioning may be by the surgeon's sense of proper pressureapplication aided by a gauged syringe for insertion of viscolubricantssuch as Synvisc, Hyalgan, Supartz and/or analgesics such as lidocainegel. The insertion of liquids to the joint per se may be directly,through a cannula to the joint space previously in place fordebridement, and or via a cannula or tube that is not part of theoriginal implant assembly. Once the joint is cleaned, the implant isinserted and appropriately fixed to avoid extrusion or dislocationthereof. This may be via attachment of the implant tabs and/or by acombination of tab use plus intended friction created by implant surfacecoverings (analogous to Velcro) or a draw string at the smaller base ofthe implant.

In some embodiments, the implant comprises a coil (spring). The coil, ormultiple coils, may be secured inside the implant. In some embodiments,the materials of the implant secure the coil or coils within theimplant. In some embodiments, the implant coil is positionedperpendicular to the primary flat first wall and/or second wall of theimplant. In some embodiments, the coil is positioned parallel to theprimary load in the joint. In some embodiments, multiple coils areprovided in the implant. In some embodiments, each coil is positionedparallel a direction of load during joint use. In some embodiments, thecoil is adapted in material and strength to fix the implant at a desiredjoint space when not under load by the bones of the joint. In someembodiments, the coil is adapted in material and strength to providecushion between the unloaded and a loaded state, and/or to provide aminimum joint spacing, for example when the coil is fully compressed. Insome embodiments, the coil has an ability to be extended past itsunloaded length (i.e. stretched), but to provide resistance to thisextension. The resistance from extension provided by the coil maycooperate with the resistance from extension provided by ligaments ofthe joint and/or by the attachments of the implant to the first boneand/or the second bone. In the case of a medial compartment arthrosiswhere the normal 6 degrees valgus degrades to a ‘bow legged’ varusdeformity, the implant may pad the damaged cartilage and cushion thejoint,—even inflating selectively as described herein. In oneembodiment, a combination of metal and polymer could stack shorter tolonger parallel (Nitinol, other metal, or polymer) coils to fit theshape of a normal meniscus so that the longer coils are at the wideperipheral portion of the meniscus (joint edge) providing stability ofthe joint not available following varus deformity or meniscectomy.Another embodiment implant comprises coils between the inner and outerlayers of the hip redundant or primary membranes.

Responsive Implants & Shifting Chambers

In some embodiments, the inflation, compliance, and or materialsintegrity with mesh, coils, or other fill materials fit the patientslimb use needs not only structurally and anatomically at the time ofsurgical placement, but during normal activities of daily living. Theimplant may be compressed in certain locations during normal loadingcycles, and compressed in other locations also during the same cycle.The implant may be responsive to this and shift the contents of abladder or chambers (whether small or large). An example of this isshown in FIGS. 10A and 10B, where in the normal gait of a person thefemur loads against the implant at the back of the joint (back of theknee), and pushes the contents of the chamber (s), toward the patella.It can be seen from this that if the angle of the femur to the tibia andload associated therewith were to shift to about 180 degrees, thecontents of the chamber(s) could likewise shift to cushion the joint asthe use of the joint required. That is, as the weight and axial load ofwalking moves the body central forces toward the ‘step off’ moment ofthat gait cycle, the chamber has also shifted, enduring oscillatingballoon (macro) or vacuolar (micro) space size changes to accommodateand buffer the actions incumbent in natural limb use. As such, in someembodiments, the implant not only restores appendicular limb anatomy ofthe bone alignments and joint spaces, it also can compress with normaluse forces and spring back to aid the best use of lever arms and jointinterstacies as bones and joints relate to each other in activities ofdaily living. This type of implant may be used in multiple joint spacesthroughout the body. To the degree the implant obtains and restores thejoint spaces and are fixed in place, they may also thus be responsiveduring use of the joint thereafter.

Smart RADs

In some embodiments, the implant comprises a microminiature recorderand/or transmitter. The recorder (i.e. sensor) may collect joint loadingdata and comprise electronics that deliver data regarding joint loading.The recorder (i.e. sensor) may collect data regarding chemical orphysiologic response at the implant location, such as the presence andcomposition of various biologic fluids at the sensor site. The sensormay be able to detect inflammatory responses in the joint. The sensormay be able to detect the spacing of the various joint components overtime or at a particular time—such as the distance between the tibia andfemur during a normal gait. The implant may comprise electronics thatdeliver data regarding joint loading or the other aspects of the jointsensed as listed herein or otherwise that could be sensed. Thetransmitters may provide feedback to the patient or to a caregiver. Thefeedback may be real-time, or may be uploaded periodically, or may beuploaded upon request. The feedback may be provided wirelessly. Thetransmitters may provide a patient an ongoing feedback and ability toadjust the joint use based to the feedback from the transmitter. Forexample, the transmitter might signal to the patient that he shouldadjust his gait to reduce the ligamentary stress in one manner oranother. In another example, the transmitter might indicate to aphysical therapist that a certain ligament is being stressed duringnormal use, and that might indicate to the therapist that the patientshould strengthen a particular muscle or muscle group to compensate forand balance the stresses in the joint. In another example, the sensorand transmitters transmits information regarding positioning,ligamentary stresses and other information to a graphic display ofreal-time feedback, enabling a surgeon to visualize and quantify jointloading and balance during implantation. Thus, a surgeon can make aninformed choice to modify implant positioning, adjust leg alignment andoptimize soft tissue balance through a full range of motion.

In some embodiments, the implant may comprise spacers which can beexpanded or reduced following implantation to adjust joint spacing andalignment. This expansion (or reduction) may occur days, weeks, or evenyears after implantation. The expansion (or reduction) may be donewithout need to open the joint in a surgery. The expansion (orreduction) may be done remotely. In some embodiments, sensors may beused to detect a need for adjustment of the joint spacing or cushioning.This may be in response to joint changes such as torn ligaments, otherwear problems, changes in body weight and thus stress changes in thejoint, or other changes, or simply due to the implant fatigue over timewhich is due to normal use but is not necessarily considered implantfailure. In certain embodiments, the implant comprises an insert thatmay be activated by the patient or health care worker. For example, limbalignment may be achieved by remotely expanding (or reducing) theimplant sizing (thickness or other specification) in a particularlocation in order to correct a varus to valgus alignment. Doing so mayhave beneficial effects on other parts of the body, such as in theappendicular skeleton (arms and legs) and axial skeleton (spine) giventhe natural symmetry. For example, a patient or care giver with theirexternal device (such as a computer or Blackberry or iPhone) may expandor reduce, the medial knee compartment by external stimulus so thatinstead of being a knee with varus deformity and bone on bone (bowlegged) the alignment was intentionally changed to normal 6 degreevalgus (knock kneed). Nevertheless, if the patient had adjusted to hisdeformity for years and abruptly “corrected” it to completely normal,his back may act up with aching symptoms of ‘out of alignment’. This isbecause the body attempts to adapt to deformity. Consequently, if alower extremity fracture healing produces a two centimeter limbshortening, the proper treatment is not to add a 2 cm shoe lift onto theinjured side, but rather to start with a one cm shoe lift. Although thismay not make the limb lengths equal, it may ‘balance the body’ asperceived by the patient. In the case of an implant as provided hereinthat could adjust or be adjusted by doctor or patient, changes can bemade to alignment and joint space, and then adjustments dealt withclinically as needed. If not via phone apps, other “black boxes” ortools such as a magnet placed externally adjacent to a medialcompartment implant could be used to change the spacing inside the jointwith an implant as described herein.

Attachment Elements and Couplers

In some embodiments the attachment elements of the implant comprisesholes through which screws or other couplers may be placed to attach theimplant to an attachment site (or connection site) in the bone of theknee. In some embodiments the attachment elements are also oralternatively called fixation elements or couplers. In some embodiments,the holes are created arthroscopically. In some embodiments the holesare pre-fabricated in the implant. In some embodiments, the holes may bemade prior to implantation based on the patient's particular anatomy. Insome embodiments, the holes are reinforced by a reinforcing material ofthe implant. The reinforcing material may be a polymer of sufficientdurometer and/or tear resistance to reinforce the screw hole. Thereinforcing material may comprise metal. In some embodiments, there isno pre-formed hole, but rather screws (or another coupler) secure theattachment tabs (which may be a non-balloon portion of the implant) tothe joint component (bone, etc) by creating their own hole whenimplanted. In some embodiments, the implant may comprise tabs that areadapted to receive staples or other couplers described elsewhere herein.In some embodiments, the elasticity of the implant may allow it tostretch over the joint end and hook or snap into place, with thetendency of the material to contract acting to hold it in place (in partor wholly).

The implants described herein may comprise attachment elements (or tabs)which may then by attached or coupled to tissue of a component of thejoint (whether to a bone or a ligament or a tendon or other jointcomponent) by a coupling device. Coupling devices (or couplers) maycomprise at least one of screws, snaps, washers, pins, sutures, sutureanchors (metal and/or biodegradable), rivets, staples (with and/orwithout teeth), stabilizers, glues, hooks of cylindrical wire orflattened sheet metal into bone holes or slots respectively. Thecoupling devices may be resorbable or not. Also, the coupling devicesmay comprise at least one of strings (i.e. drawstrings), reigns, lassos,sutures, and lanyards. The strings, reigns, lassos, sutures, and/orlanyards may join with themselves and/or other coupling devices. Thestrings, reigns, lassos, sutures and/or lanyards may be directed notonly into bone with or without anchors, but also through ligaments,tendons or loose segments of cartilage that the surgeon intends topreserve.

The posterior of the knee can be difficult to access without disturbingjoint components (or in order to minimize such disturbance) such astendons, ligaments, etc. Thus, in some embodiments, the implantcomprises strings, reigns, lassos, and/or lanyards that may pass fromthe posterior of the implant via the intercondylar notch anteriorly tojoin with themselves and/or other coupling devices. These couplers maybe pre-coupled to the implant, and the implant and its couplers may beconfigured to be pulled (or cinched) from the anterior of the implantonce the implant is in its general location relative to the condyle inorder to finally position the implant about the condyle—in particular inorder to cinch the implant about the posterior of the condyle. Likewise,in some embodiments where the implant is pre-molded, the coupler asdescribed are adapted to move the implant to its final position withconformity to the condyle's posterior with minimal disturbance to thejoint structures at the joint's posterior (minimal cutting, minimalmoving, and or minimal detachment, for non-limiting example).

In some embodiments, the implant comprises a skirt (or sleeve) thatconforms to the contours of the bone (whether a condyle of the femur, apatella, or a tibia) as a coupler.

In some embodiments, a screw through tab having reinforced center holesmay be part of the implant. For example, the implant may comprisepolymer covered metal washer holes. The screw may go through the holes.Another embodiment may comprise a staple having spikes as shown in FIGS.13A-13D. FIGS. 13A-13D depict multiple views of a staple adapted tocouple an implant to a bone of the joint. FIG. 13A depicts an embodimentof an implant 20 having a tab 10 a that is coupled to bone using astaple 12. FIGS. 13B & 13C depict a staple 12 as described herein havingteeth 18. FIG. 13C depicts an embodiment of a tab 10 a that is coupledto bone using a staple 12 having teeth 18. Combinations of spikes andscrews may be used in some embodiments, or combinations of othercouplers. The implant may be configured to allow a surgeon the option ofseveral types and sizes of couplers, as each patient differs with regardto size and depth of lesion, bone stock, regrowth capability, andcompliance with advised recovery, and each surgeon has his own strengthsand comforts when working with such implants.

The edge of the implant may have a depending skirt to secure or anchorthe implant to the end of bone (femur), but may have one or moredepending tabs (or appendages) that may be employed for similarfunctions as are discussed in other embodiments. The skirt (and/or tabs,and/or appendages) may tightly fit about the end of the femur, or theskirt can be secured by adhesive (e.g. HydroMed, Carbopol 934p,Polycarbophil AA1, xanthum gum, hydroxypropyl cellulose). Moreover, thelower portion of the skirt may be secured by a purse string suture or asuitable strand (elastic or tied) that is tightly bound about theoutside of the skirt.

FIGS. 12A, 12B, and/or 12C alternatively may be used to describe a patchimplant or a unicompartment knee implant described herein, havingappendages 4 a, 4 c, extending from a balloon 6 and including holes 8 a,8 b, 8 c, and/or tabs 10 a, 10 b. 10 c, 10 d, 10 e, 10 f, which may beused with couplers (not shown) to couple the implant to a bone of theknee joint (which may be the femur, the tibia, or the patella). Featuresshown in FIGS. 12A, 12B, and or 12C are common to both theunicompartment knee implant (also discussed elsewhere herein) and thepatch implant (also discussed elsewhere herein), although dimensions maydiffer as described elsewhere herein.

FIGS. 13A-13D depict multiple views of a staple 12 adapted to coupleimplant 14 (such as those described herein) to a bone 16 of the joint.FIG. 13A depicts a staple 12 coupling a tab 10 a of an appendage 4 a tothe bone 16 of the joint (wherein the portion of the staple 12 embeddedin the bone 16 is shown as a dashed line). FIG. 13B depicts a view of astaple 12 having teeth 18 to grasp the tab 10 a of the implant 14.Similarly, FIG. 13C depicts a view of a staple 12 having teeth 18 tograsp the tab 10 a of the implant 14. FIG. 13D depicts a staple 12attaching the tab 10 a of an implant to a bone 16, the dotted lines showthe portion of the tab 10 a that is compressed by the staple 12 andteeth 18 thereof.

In some embodiments, the implant is configured such that the tabs and/orcouplers of the implant couple to the bone where there is no naturalcartilage. In some embodiments, the implant may be adapted by thesurgeon at the time of surgery such that the tabs are positioned wherethere is no natural cartilage.

In some embodiments, the implant comprises a tab and a hook that couplesto the tab by wrapping around a component of the knee and securing thetab to the hook. In some embodiments, the implant comprises a tab and ahook that couples to the tab by wrapping around a condyle of the kneeand securing the tab to the hook. In some embodiments, the implant isconfigured to wrap around a condyle of the knee and to secure a firstappendage to a second appendage of the implant. In some embodiments theappendages are secured by couplers described herein. In someembodiments, the implant is pre-formed to fit to the condyle in such awrapping manner.

In some embodiments, the implant comprises a methyl methacrylate what isplaced into a balloon chamber that fits into a bone hole. Such anembodiment would generally fix the implant to the bone once the methylmethacrylate cures to a solid.

In some embodiments, the implant can be anchored with generic availablesutures and suture anchors fixing and positioning material to bone withproper tensioning.

In some embodiments, fixation may comprise various methods and elements.For example the fixation to a bone (the first, the second or the thirdbone) may comprise any one of or a combination of a screw, a snap, apin, a staple, bone in-growth materials, glue, a nanocomposite, andcement. The implant may comprise a snap fit option for fixation. Theimplant itself may be pre-molded to cup the first bone of the device, orthe second bone of the device. The implant may instead have a snap-likedevice which fixes the device to the bone (the first, second, and/orthird bone). In some embodiments, fixation comprises glue. In someembodiments, fixation comprises a nanocomposite. In some embodiments,the nanocomposite comprises a polyurethane hierarchical nanocomposite.Fixation may comprise gluing a nanocomposite to the implant. In otherembodiments, fixation comprises bone in-growth materials. For example,bone in-growth may be achieved as described in Vasanji A (2012). In someembodiments the patient's preoperative x-rays, MRI, CT scan, or physicalmeasurements are coordinated with implant custom fit options providingfor translation of pathophysiological data into solid works and rapidprototypes. This may provide the forum for anatomic fit of the implantto the patient. Optionally, the implant may be selected from a set ofpre-selected sizes of implants and then the device may have inherentmalleability which is used to couple the implant to the bone end.

In some embodiments, the implant comprises a rim comprising metal at theedge or a portion of the edge of the implant which may comprise a holeor more than one hole through which a fixation element (snap, screw,staple, other, etc.) or more than one element can be placed to fix theimplant to the bone. The rim may comprise Nitinol or another metal(memory metal or deformable).

The implant may be shaped to form a joint cap which is fixed to a firstbone or a second bone or a combination thereof with a fixation elementsuch as a screw or staple or cement or another means or combination ofthese or others as described herein. Cementing the implant in place isan alternative or may be used with other fixation elements (screws,snaps, ties, hooks, staples, etc). In some embodiments the implant issecured in place only by the nature of its location and placement withinthe joint space. That is, it may naturally be held in place by thesurrounding structures (tissue, bone, ligaments) as well as its owngeometry in three dimensions. In some embodiments, fixing of the implantto bone is achieved by combining autograph, allograph, xenograph, and/orprosthetic structures.

In some embodiments, the implant comprises a polymer joint cap that maybe used similarly to the femoral component of a total knee replacementcement arthroplasty or like a hip resurfacing. In certain cases,cartilage may be sacrificed exposing more bone beneath the implant, andcement could be used as a traditional fixation technique. In certainembodiments, specific portions of cartilage can be removed to allowattachment of the implant undersurface with the bone by localizedapplications of cement, bone in-growth, tacking devices, countersunkscrews, or Velcro like constructs wherein opposing surfaces are set tofix. In an implant embodiment employing a cement for fixation, theanterior cruciate ligament could still be saved maintaining jointstability and proprioception.

A snap fit fixation element (“snap”) may alternatively (or additionally)be used. A snap may be a protuberance off the posterior implant surfacemay be used. The snap may comprise a mushroom shaped peg that may insertinto predrilled bone holes. The holes in some embodiments are ofcorresponding shape to the peg (upside-down mushroom-shaped holes, orsimilarly shaped holes). The holes in some embodiments are columnarshaped holes. The holes may be at the periphery (edge) of the implant asit opposes bone, or generally located as noted herein where otherfixation elements are located (e.g. see FIGS. 1-4B, 11, 12 at least).The snap may also fit into more central posterior implant areas. Withthe natural effects of joint fluid and temperature on hydrophilicpolymers, the snap may be designed as to increase stability by swellingbeneath the joint cortical surface in the early post operative interval.Implant removal may be facilitated by placing a cooling device over thesnap site to shrink or loosen the attachment. In some embodiments thepeg of the snap is one of: about 1 mm to about 10 mm in diameter, about2 mm to about 8 mm in diameter, about 3 mm to about 6 mm in diameter,about 4 mm to about 5 mm in diameter, about 4.5 mm in diameter, 1 mm to10 mm in diameter, 2 mm to 8 mm in diameter, 3 mm to 6 mm in diameter, 4mm to 5 mm in diameter, and 4.5 mm in diameter. In some embodiments themushroom head of the snap is one of: about 1 mm to about 10 mm indiameter, about 2 mm to about 8 mm in diameter, about 3 mm to about 6 mmin diameter, about 4 mm to about 5 mm in diameter, about 4.5 mm indiameter, 1 mm to 10 mm in diameter, 2 mm to 8 mm in diameter, 3 mm to 6mm in diameter, 4 mm to 5 mm in diameter, and 4.5 mm in diameter Thesnap or protuberances may have a narrow base that extendsperpendicularly from the tabs and/or implant posterior surface. Thewider sphere as compared to the diameter of the snap columnar pedestalfits into a predrilled bone hole that matches the location to be fixed.In another embodiment, the snap may be more like anchor which expandsinto the bone upon insertion, much like a drywall anchor acts. Materialcompliance allows the distal snap to enter through cortical tocancellous bone. Exposure to joint fluid and bode temperature can expandthe snap wherein the snap comprises a hydrophilic polymer to secureimplant apposition. In some embodiments, a mushroom shaped protuberanceoff the posterior of the polymer joint implant is used, with stiff pegsthat push connected spheres through a predrilled cortical bone hole. Thejoint implant may be cap-like holding to the bone by internal elasticityof the implant and further held by the fixation elements which may besnaps or other elements. In some embodiments, a drill into cortical holecuts a broader cancellous swath to create a location for the ball of thesnap. For example the peg hole may be 5 mm, while the mushroom cap headhole section diameter may be 7 mm. Other sizes may be appropriate forthe peg hole such as about 1 mm, about 2 mm, about 3 mm, about 4 mm,about 5 mm, about 6 mm, about 7 mm, about 8 mm. Other sizes may beappropriate for the mushroom cap head hole section, such as about 2 mm,about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm,and about 9 mm. A hydrophilic polymer of the snap may then swell andhold the implant into place.

Other variations of fixing an implant to a bone may be known to one ofskill in the art, and may include (but is not limited to) cross pinssuch as those used for ACL graft fixation, whip stitches with newerstrong sutures as OrthoCord, or combinations of the above or othersnoted herein.

It should also be recalled that whereas the usual location of implantsis over the major surface of a joint, the minor surfaces of joints maybe selected optionally or additionally for coverage by an implantdepending on the clinical need. In another iteration for fixation,magnets inside pegs or protuberances can allow for size adjustmentinternally or externally so as to engage a locking mechanism of implantto bone end.

In-Growth Features

In addition to the general in-growth that may occur based on the implantfeatures described herein, the implant undersurface (adjacent the femur)may comprise an in-growth matrix. In some embodiments, at least aportion of the implant adjacent to the femur comprises bone in-growthmaterials. Such an implant can be attached by a series of tabs with orwithout holes, using screws, rivets, stabilizers, staples, tacks,washers, pins, snaps, or Sutures and suture anchors, for non-limitingexample. The polymer of the implant substitutes for periosteum when theimplant comprises living chondrocytes (e.g. Carticel) as the in-growthmatrix on a surface of the implant. The polymer of the implantsubstitutes for periosteum when the implant comprises livingchondrocytes (e.g. Carticel) as the in-growth matrix within an implantembodiment configured to reveal and/or release said chondrocytes overtime and/or upon implantation.

The bone in-growth undersurface may be used for long term fixation ofthe tabs or rim. That is, whereas it is important for the surgery tosecure the implant to the joint surface in the most desirable correctivelocation, it is also important in some embodiments to prepare theanatomic undersurface of bone by abrading it, removing about 0.5 mm ofcortical bone so as to expose the underlying oxygen, blood, andnutrients of the patient to the undersurface of the implant that cangradually become incorporated into the limb bone. As this healing occursover the course of weeks and months to one year post operation, thelocalized tacking sites may become less relevant and potentially inert.Thus, in some embodiments, the implant may comprise a biodegradable(bioresorbable) polymer or other material. The couplers may additionallyand/or alternatively be biodegradable or durable (non-bioabsorbable).Once the implant is in place, it may serve to at least one of: paddefects, cushion the joint, and restore the original damage to the jointcomponents. The end goal is to apply minimally morbid treatment that mayrefurbish arthritic limb regions, leaving only the small skin scar andremote memory of the healed physical mishap.

Undersurface implant materials may involve used of the art and sciencefrom Artelon or Gore-Tex research, as each has advantages andlimitations. Several implant options per joint damage area may beavailable to enjoy the primary surgeons manipulation to fit theclinically recovery requirements best.

In some embodiments the implant comprises an in-growth patch on at leastone of the first portion configured to engage the femur, the secondportion configured to engage the second bone (whether the tibia or thepatella), the side portion, and the appendage. In some embodiments,tissue is removed to facilitate in-growth.

The walls of the implant embodying features of the invention may becomposite structures. For example, the innermost layer may be imperviousto preclude escape of inflation or other filling media, a central layermay be porous or otherwise contain treatment or cell regenerationagents, and the outer layer may be a thin, but strong layer of athermoplastic, such as a thermoplastic polyurethane for non-limitingexample, which has microporosity sufficient to allow passage or egressof treatment or cell regeneration agents from the central layer (orsecond layer). The degree of microporosity to enable egress of treatmentor cell regeneration agents from the central layer is found in polymerlayers such as Chronoflex (e.g., ChronoFlexAR®, ChronoFlex AL®,ChronoFlec C®) or BIONATE (e.g., BIONATE I, BIONATE II, BIONATE 55D,BIONATE 65D, BIONATE 75D, BIONATE 80A, BIONATE 90A, BIONATE 55 orBIONATE 80). The external wall (and/or the bone engaging surface) of theimplant may be coated and/or impregnated with a latticework of polymerthat is surface sprayed or layered on the outside (or bone engagingsurface) of the implant to promote cartilage tissue regeneration. Thismost external surface coating may contain living chondrocytes (forexample, as is provided in the Carticel procedure by the Genzymecompany), and/or may contain stem cells with or without directed genemutations to enhance adherence of the coating to the implant. The boneengaging surface may comprise peaks and troughs. The living cells may beimposed in between (and/or provided in the) troughs of the implantsurface while the surface areas of prominence (the peaks of the surface)may be used for at least one of: space validation, traction, and cellprotection.

The implant embodying features of the invention may be used in a seriesof treatments wherein the first treatment involves use of autologous orminimally manipulated allograph interpositional tissues or xenograph,the second treatment involves the use of the same type of tissue addedto stem cells or chondrocytes and the third treatment involvingdeployment of the implant if the first two fail or are ineffective.

The implant may comprise materials which allow for bone in-growthfollowing implantation. In-growth may be facilitated by havinginterstices (or chambers) in the implant or in the fixation elementswhich are in the range of at least one of: about 10 microns to about2000 microns, about 50 microns to about 1000 microns, about 100 micronsto about 500 microns, about 300 microns to about 500 microns 10 micronsto 2000 microns, 50 microns to 1000 microns, 100 microns to 500 microns,and 300 microns to 500 microns. In some embodiments, the chambers aresized to mimic the latticework of trabecular bone. In some embodiments,the chambers are formed by forming the implant using beads of the sizesnoted above (e.g. 300 microns to 500 microns) and thereafter dissolvingor otherwise breaking the beads such that interstices are left in theimplant of the size of the beads. In an alternative, the beads maycomprise a pharmacologic or other active agent which is absorbed or usedby the body once implanted, and over time the interstices left by thebeads (now gone due to absorption or use by the body) promote in-growth.Various methods known to one of skill in the art may be used to preparethe implant surface toward maximally effective union to bone.

Pharmacologics and Therapeutic Agents & Delivery Thereof to VariousLocations

In some embodiments the implant may comprise vacuoles of pharmacologicsubstances. The vacuoles may be on a bone-engaging portion of theimplant. In some embodiments, the implant comprises bubbles comprisingan active substance such as a pharmacologic substance or other activesubstance. In some embodiments, the implant comprises spaces filled withan active substance such as a pharmacologic substance (pharmacologicagent) or other active substance (active agent). In some embodiments,the active substance comprises iatrogenically gene mutated cells. Insome embodiments, the implant may be inserted into the vacated spacefollowing removal of an infected routine total joint replacement.Current treatment of infected prostheses range from IV antibiosis,through arthroscopic washout to single or two stage replantations. Withthe worst infection the joint is often debrided of the prostheticcomponents and old cement, and then filled with new bone cement that isimpregnated with antibiotics, leaving the hardened materials in place6-12 months. During this interval 6-12 weeks IV antibiotics aretypically used. In this situation if implants as noted herein wereinserted with a calculated egress of antibiotics from the polymercontainer, both increased concentration of local antibiotics anddecreased systemic side effects can benefit the patient. Further, sincethe polymer is both robust and compliant, use of the infected jointbeing treated is more realistic and comfortable, with a “bag ofantibiotics and air” as opposed to a “chunk of cement.”

Similar use of implants as noted herein for localized resected bone orsoft tissue tumors may allow for drug delivery. Substances that can bedelivered via implants noted herein are limitless, though may include(for non-limiting example) antibiotics, anti-fungal and Tb agents,anti-gout, anti-rheumatoid, and anti-tumor. Implants in certainembodiments may specifically elute contents via one or more portals fromthe primary chamber, and/or from a material liner of the implant.Implants in certain embodiments may specifically elute contents via themultiple chambers (in the 1 micron to 1 mm size) which are filled withthe active and/or pharmacologic agent. Alternatively, the implant mayhave a port to an external source (outside the body or outside the spacewhere the implant has been placed) of therapeutic agent which then maybe delivered by elution or other manner from the implant itself. Stemcells such as living chondrocytes can be disbursed immediately and/orover time for regenerative purposes to regrow joint surface cartilage.Polymer layers of the implant material, in certain embodiments, may ormay not be biodegradable. Disease fighting orthobiologics, both livingand laboratory, can be dispensed via the implants.

Active agent delivery with implants as noted herein may be from theirreservoirs wherein the agent is encapsulated in a polymer shell.Optionally matrices with entrapped polymer can elute active agents fromthe network, and/or the matrix can dissolve as a planned rate.

Still other iterations are contemplated. The implant may comprisemicelles can be nano-sized hydrophilic shells that make up an implantlayer that protects a core agent. Cell specific targeting drugs designto attach particular molecules may be delivered via implants notedherein as from a vesicle elution or matrix diffusion. For example,Gleevac targeting a GIST tumor molecule may specific address a clinicalcancerous problem. Doxorubicine, a hydrophyobic anticancer agent at beemitted via polymer deliver from either a solid or inflated materialinterface between joint surfaces and/or from a ballooning aspect of thatinterpositional arthroplasty. Membranes (or walls) of the implants canbe of singular or multiple layers with various relationships to eachproximate layer so as to absorb or exude drugs using electroactivepolymers through controlled transport(dopants) in and out of membranes.Hydrogels can be tailored to swell releasing entrapped molecules/cellsthrough weblike matrices of the implant. Triggers from release ofsubstances from certain embodiments of the implant can be internal orexternal, involving chemical factors such as pH, electromagnetic factorsas magnetic fields, temperature variables as when 37 degrees bodytemperature induces an additional 30% pliability to the polymer wall, orultrasonic release of vacuole content. Calculated mechanical vacuolewall thickness in relation to predictable acute, subacute or chronicintra-articular joint forces invoked by movement and limb use canrelease internal substances abruptly and/or over time.

Dendritic Macromolecules may deliver agent en masse from certainembodiments of the implant. The delivery in such situations may be viacontrollable size and structure, and may incorporate individual agentmolecules or “hubs” via covalent bonds. Any combination of thenanoscopic developments can be created or assembled into the implantsdescribed herein and can be distributed, or oozed, or leaked, orexpulsed from, or absorbed into as cleansing a noxious environment, orany combination thereof. Combined alternating forces such as materialsthat suck up or absorb noxious leukokynins or cathepsins while releaseduseful viscolubricants such as Synvisc, Hyalgan or Orthovisc can beconstructed to accommodate clinical need consistent with physical jointdamage mandates or aligned with and consider of the natural history ofdisease processes so as to maximize either ones anticipated inevitablechronic deterioration or to thwart the adverse affects delayingdegradation from arthritic or pathophysiologic processes.

Patient Symptoms

Symptoms for the patient requiring an implant described herein mayinclude, for non-limiting example, osteoarthritis or rheumatoid or goutyarthritis.

Total Knee Arthroplasty (Dual Compartment):

Provided herein is an implant for placement on both condyles (medial andlateral) of the distal femur. In some embodiments, this is called a dualcompartment implant since it covers both condyles of the femur. Such animplant comprises at least one interior (or inflatable chamber), and insome embodiments comprises a plurality of inflatable chambers (orinteriors).

In some embodiments, the implant covers the “H” distal femoral cartilagesegment (made up of both femoral condyles and the trochlear groove inbetween). The implant may absorb diffuse force, endure the millions ofannual cyclic loads of both knee joints (including the patella-femurjoint and the femur-tibia joints), along with rotational and shearforces up to six times body weight, at least.

In some embodiments, the implant comprises attachment tabs or attachmentelements over the sides of both condyles medially and laterally. In someembodiments, the implant comprises attachment tabs or attachmentelements in the intercondylar notch (or slot). In some embodiments, theimplant comprises attachment tabs or attachment elements superiorly atthe distal end of the femur anteriorly. In some embodiments, posteriorreigns or suture-like lanyards cinch up the implant from inside theposterior intercondylar notch toward another connection site around thefemur.

The posterior of the knee can be difficult to access without disturbingjoint components (or in order to minimize such disturbance) such astendons, ligaments, etc. Thus, in some embodiments, the implantcomprises strings, reigns, lassos, and/or lanyards that may pass fromthe posterior of the implant via the intercondylar notch anteriorly tojoin with themselves and/or other coupling devices. These couplers maybe pre-coupled to the implant, and the implant and its couplers may beconfigured to be pulled (or cinched) from the anterior of the implantonce the implant is in its general location relative to the condyle inorder to finally position the implant about the condyle—in particular inorder to cinch the implant about the posterior of the condyle. Likewise,in some embodiments where the implant is pre-molded, the coupler asdescribed are adapted to move the implant to its final position withconformity to the condyle's posterior with minimal disturbance to thejoint structures at the joint's posterior (minimal cutting, minimalmoving, and or minimal detachment, for non-limiting example). In someembodiments at least a portion of the ligamentary structure of the kneeis spared.

Although this description focuses on the distal femur as it articulateswith the retropatellar and proximal tibial cartilages implants asdescribed generally herein may be also and/or alternatively be used inconjunction with the tibia and/or the patella. Furthermore, separateand/or connected implant components may be inserted to restore naturalfunction to the knee. In some embodiments whereas the implant caps themajor joint surface and opposes remnant cartilage, the surgeon may electto place the implant so that it opposes metal, polymer, or anothersurface reconstructive material.

Coupling devices to be used as part of the dual compartment implant mayinclude any of those mentioned or described herein, for example. Suchcoupling devices may comprise at least one of strings (i.e.drawstrings), reigns, lassos, sutures, and lanyards. The strings,reigns, lassos, sutures, and/or lanyards may join with themselves and/orother coupling devices. The strings, reigns, lassos, sutures and/orlanyards may be directed not only into bone with or without anchors, butalso through ligaments, tendons or loose segments of cartilage that thesurgeon intends to preserve.

FIG. 1 depicts an embodiment of the implant 20 in a 2D view configuredfor dual condyle (distal femur) coverage. FIG. 1 depicts an embodimentof the knee implant 20 having appendages 4 a, 4 b, 4 c, 4 d, includingholes 8 a, 8 b, 8 c, 8 d and tabs 10 a, 10 b extending from a balloon 6and including slots 26 a, 26 b to accommodate ligaments (not shown) ofthe knee joint. Couplers as described elsewhere herein may be used tocouple the implant 20 to the distal femur. In some embodiments, theremay only tabs, only holes, or only appendages, or combinations thereof.In some embodiments, there may be other ways to couple the implant tothe distal femur, as described elsewhere herein (sutures, drawstrings,skirts, glue, etc). In some embodiments, the tabs 10 a, 10 b containholes. In some embodiments, the couplers create the holes 8 a, 8 b, 8 c,8 d, or other holes (not shown) when the implant is placed against thedistal femur 24. In some embodiments, the holes are pre-formed in theappendage prior to implantation. In some embodiments, the holes arereinforced as described elsewhere herein. In some embodiments, the holesare within the peripheral rim of the knee implant. In some embodiments,the holes are within the region of the intercondylar notch mediallyand/or laterally. In some embodiments, the holes are through thepolymer. In some embodiments, the holes are through a reinforced rim. Asshown here, the appendages in some embodiments may be different in shapeand/or size to accommodate the differences in condyle size and/or shape.For example the medial condyle tends to be larger than the lateralcondyle, and thus appendage 4 d that is intended to wrap over the medialcondyle may be longer and/or wider than the appendage 4 c intended towrap over the lateral condyle. Likewise, the slots may be different inshape and/or size and/or position to accommodate the ligaments and/ortendons of the joint or other structures and functions of the joints ofthe knee, and to allow for placement of the implant with minimaldisturbance (cutting, manipulation, for example) of the joint componentssuch as tendons, ligaments, and other soft or hard tissues. For example,slot 26 a is shaped and positioned to accommodate the cruciate ligamentsof the knee, at least. In some embodiments, the implant as shown in FIG.1 can have regions 4 a, 4 b, 4 c, 4 d where no inflation exists and maybe composed of solid or compliant materials. In some embodiments, theimplant comprises a Dyneema® mesh. The implant may comprise Dyneema®fiber. In some instances, the implant comprises Dyneema Purity® fiber.In some embodiments, the implant comprises a Dyneema Purity® UG fiber.In some embodiments, the implant comprises a Dyneema Purity® VG fiber.The implant may comprise a fiber. The implant may comprise apolyethylene. The implant may comprise a polyethylene fiber.

FIG. 2 depicts an embodiment of the knee implant 20 having appendages 4a, 4 b, 4 c, 4 d, including holes 8 a, 8 b, 8 c, 8 d and tabs 10 a, 10 bextending from a balloon 6 and including slots 26 a, 26 b to accommodateligaments of the knee joint as well as side views of the same kneeimplant. Couplers as described elsewhere herein may be used to couplethe implant 20 to the distal femur. In some embodiments, there may onlytabs, only holes, or only appendages, or combinations thereof. In someembodiments, there may be other ways to couple the implant to the distalfemur, as described elsewhere herein (sutures, drawstrings, skirts,glue, etc). In some embodiments, the couplers create the holes 8 a, 8 b,8 c, 8 d, or other holes (not shown) when the implant is placed againstthe distal femur. In some embodiments, the holes are pre-formed in theappendage prior to implantation. In some embodiments, the holes arereinforced as described elsewhere herein. As shown here, the appendagesin some embodiments are different in shape and/or size to accommodatethe differences in condyle size and/or shape. For example the medialcondyle tends to be larger than the lateral condyle, and thus appendage4 d that is intended to wrap over the medial condyle may be longerand/or wider than the appendage 4 c intended to wrap over the lateralcondyle. Shown in the embodiment depicted in FIG. 2 are the differenthole placements from the side view, showing the differences inpositioning of the holes to accommodate the differences in anatomicstructure and size of the condyles. Likewise, the slots may be differentin shape and/or size and/or position to accommodate the ligaments and/ortendons of the joint or other structures and functions of the joints ofthe knee, and to allow for placement of the implant with minimaldisturbance (cutting, manipulation, for example) of the joint componentssuch as tendons, ligaments, and other soft or hard tissues. For example,slot 26 a is shaped and positioned to accommodate the cruciate ligamentsof the knee, at least. Additionally, as shown in the side views of theembodiment shown in FIG. 2, the balloon has a first wall 28 adapted tobe adjacent the femur that is of a greater thickness than the secondwall 30. In some embodiments, the first wall 28 is configured to havetherapeutic benefits (pharmacologic, healing, and/or in-growthproperties) as described elsewhere herein. The second wall 30 mayadditionally and/or alternatively be configured to have a therapeuticeffect (pharmacologic, healing, and/or in-growth properties).

Nevertheless, differing thicknesses of the first wall 28 and the secondwall 30 are not necessarily required in order to impart the therapeuticbenefits (pharmacologic, healing, and/or in-growth) described elsewhereherein. For example, FIG. 3 depicts an embodiment of the knee implant 20having appendages 4 a, 4 b, 4 c, 4 d, including holes 8 a, 8 b, 8 c, 8 dand tabs 10 a, 10 b extending from a balloon 6 and including slots 26 a,26 b to accommodate ligaments of the knee joint as well as side views ofthe same knee implant. Couplers as described elsewhere herein may beused to couple the implant 20 to the distal femur. In some embodiments,there may only tabs, only holes, or only appendages, or combinationsthereof. In some embodiments, there may be other ways to couple theimplant to the distal femur, as described elsewhere herein (sutures,drawstrings, skirts, glue, etc). In some embodiments, the couplerscreate the holes 8 a, 8 b, 8 c, 8 d, or other holes (not shown) when theimplant is placed against the distal femur. In some embodiments, theholes are pre-formed in the appendage prior to implantation. In someembodiments, the holes are reinforced as described elsewhere herein. Asshown here, the appendages in some embodiments are different in shapeand/or size to accommodate the differences in condyle size and/or shape.For example the medial condyle tends to be larger than the lateralcondyle, and thus appendage 4 d that is intended to wrap over the medialcondyle may be longer and/or wider than the appendage 4 c intended towrap over the lateral condyle. Shown in the embodiment depicted in FIG.3 are the different hole placements from the side view, showing thedifferences in positioning of the holes to accommodate the differencesin anatomic structure and size of the condyles. Likewise, the slots maybe different in shape and/or size and/or position to accommodate theligaments and/or tendons of the joint or other structures and functionsof the joints of the knee, and to allow for placement of the implantwith minimal disturbance (cutting, manipulation, for example) of thejoint components such as tendons, ligaments, and other soft or hardtissues. For example, slot 26 a is shaped and positioned to accommodatethe cruciate ligaments of the knee, at least. Additionally, as shown inthe side views of the embodiment shown in FIG. 3, the balloon has afirst wall 28 adapted to be adjacent the femur that is of approximatelythe same thickness than the second wall 30. In some embodiments, thefirst wall 28 is configured to have therapeutic benefits (pharmacologic,healing, and/or in-growth properties) as described elsewhere herein. Thesecond wall 30 may additionally and/or alternatively be configured tohave a therapeutic effect (pharmacologic, healing, and/or in-growthproperties). The balloon 6 may be singular as depicted, or in certainembodiments, include a plurality of microscopic vesicular structures.

FIG. 4A depicts an embodiment of the knee implant 20 having appendages 4a-4 d including ten tabs 10 a-10 j extending from a balloon 6 andincluding a slot 26 a to accommodate components (such as ligaments orother tissues whether soft tissues, hard tissues, tendons, and/orothers) of the knee joint (not shown). The tabs 10 a-10 j are not shownwith holes in this embodiment, however if screws are used as couplers,such holes may be pre-drilled or formed in situ by the screws.Additionally and/or alternatively, staples, washers, pins, snaps, orsutures may be used (as described elsewhere herein) in order to couplethe implant to the bone (femur, for example). Other couplers asdescribed elsewhere herein may also and/or alternatively be used in thiscoupling process. Furthermore, the number of tabs may be fewer orgreater than the ten depicted in order to achieve optimal placement andcoupling to the bone. For example, FIG. 4B depicts an embodiment of theknee implant 20 having appendages 4 a-4 d including eight tabs 10 a-10 hextending from a balloon 6 and including a slot 26 a to accommodatecomponents (such as ligaments or other tissues whether soft tissues,hard tissues, tendons, and/or others) of the knee joint (not shown). Incertain embodiments, the implant comprises 0, 1, 2, 3, 4, 5, 6, 7, 8, 9,or 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and/or 20 tabs. The tabs maybe located on either side of the condyles, including the superior, mid,and posterior portions. Any tab may be also and/or alternatively locatedinside the medial and intercondylar notch.

FIG. 5 depicts an embodiment of the knee implant 32 curved to simulatecurvature about the condyles of a femur, the implant having appendages 4a-4 d extending from an uninflated balloon (not shown) and includingslots 26 a, 26 b to accommodate components (such as ligaments or othertissues whether soft tissues, hard tissues, tendons, and/or others) ofthe knee joint (not shown). This figure also shows an implant comprisinga solid compliant material, having no balloon whatsoever. The implantmay comprise additional curvatures and/or slots to accommodate otherligaments and/or tissues. In some embodiments, the implant is configuredto conform about various hard and/or soft tissues of the joint, such asbone, ligaments, tendons, etc. In some embodiments, the balloon isinflated once the implant is positioned within the joint. In otherembodiments, the balloon is partially inflated prior to being positionedwithin the joint. In other embodiments, the balloon is at leastpartially inflated prior to being positioned within the joint. In someembodiments, the balloon is fully inflated prior to being positionedwithin the joint. In some embodiments, the implant is configured toallow an operator to adjust the amount of balloon inflation in situ(whether by adding inflation medium or removing inflation medium, orboth, or neither). Couplers as described elsewhere herein may be used tocouple the implant 32 to the distal femur.

FIG. 6A depicts a top-down view of an embodiment of the knee implant 32curved to simulate curvature about the condyles of a femur, the implanthaving appendages 4 a-4 d extending from two inflated balloons 6, 34 andincluding a slot 26 a to accommodate components of the knee joint. FIG.6B depicts a bottom-up or anterior oblique view of the same embodimentof the knee implant 32 curved to simulate curvature about the condylesof a femur, the implant having appendages 4 a-4 d extending from twoinflated balloons 6, 32 and including a slot 26 a to accommodatecomponents of the knee joint. Couplers as described elsewhere herein maybe used to couple the implant 32 to the distal femur. As shown in FIGS.6A and 6B, the appendages 4 a-4 d in some embodiments are different inshape and/or size to accommodate the differences in condyle size and/orshape. For example the medial condyle tends to be larger than thelateral condyle, and thus appendage 4 d that is intended to wrap overthe medial condyle may be longer and/or wider than the appendage 4 cintended to wrap over the lateral condyle. Likewise, the dimensions ofthe balloon 34 that is adapted for placement over the medial condyle maybe a different shape and/or size than the balloon 6 over the lateralcondyle (the medial condyle being larger, thus the balloon 34 may belarger for that location) Alternatively and/or additionally, asdescribed elsewhere herein, for various reasons such as injury,realignment needs, injury, etc, there may be a need for morereconstruction of one condyle than needed for the other, thus theinflation medium might be different in one balloon (or a portionthereof) than in the other balloon (or another chamber within the sameballoon), or there may be need for a different shaped balloon in onelocation than in another location. Embodiments provided herein canaccommodate these requirements based on materials of fillers,appendages, balloons, walls, and dimensions and chamber options of theimplant and its components.

FIG. 7 depicts a top-down view of an embodiment of the knee implant 32curved to simulate curvature about the condyles of a femur, the implanthaving appendages 4 a-4 d extending from an inflated balloon 6 andincluding slots to accommodate components of the knee joint. Couplers asdescribed elsewhere herein may be used to couple the implant 32 to thedistal femur. As shown here, the appendages 4 a-4 d in some embodimentsare different in shape and/or size to accommodate the differences incondyle size and/or shape. For example the medial condyle tends to belarger than the lateral condyle, and thus appendage 4 d that is intendedto wrap over the medial condyle may be longer and/or wider than theappendage 4 c intended to wrap over the lateral condyle. Likewise, thedimensions of the portion of the balloon that is adapted for placementover the medial condyle may be a different shape and/or size than theportion of the balloon over the lateral condyle (the medial condylebeing larger, thus the balloon may be larger for that location)Alternatively and/or additionally, as described elsewhere herein, forvarious reasons such as injury, realignment needs, injury, etc, theremay be a need for more reconstruction of one condyle than needed for theother, thus the inflation medium might be different in a portion orchamber of an implant embodiment having a plurality of inflationchambers in a single balloon, or there may be need for a non-symmetricballoon. Embodiments provided herein can accommodate these requirementsbased on materials of fillers, appendages, balloons, walls, anddimensions and chamber options of the implant and its components.

FIG. 8 depicts a side view of an embodiment of the knee implant 32curved to simulate curvature about at least one condyle of a femur, theimplant having appendages 4 b, 4 d extending from an uninflated balloon(not shown). This depiction covers the maximum anticipated distalfemoral contour; other iterations may be smaller, or shorter coveringlimited areas of the circumference of the femoral curvatures. Thisfigure also provides a lateral view for a solid implant (without achamber therein) wherein the material thickness and/or layering providecushioning.

FIG. 9A depicts a side view of an embodiment of the knee implant 20curved about at least one condyle 22 of a femur 24, the implant 20having appendages 4 b, 4 d extending from an uninflated or minimallyinflated balloon 6. In this view, the knee is positioned essentially inextension (straight), showing the tibia 36, fibula 38, and patella 40 ofthe knee. Note that although there would be other joint structures andknee structures in a true depiction of an implant positioned in theknee, this view of the implant and bones is greatly simplified for easeof understanding of the implant and the joint relative (and approximate)positions and placement. Couplers as described elsewhere herein may beused to couple the implant 20 to the distal femur 24 and/or the condyle22 thereof (in this image the medial condyle, at least since it isprimarily a one-side view of the joint and implant). For the sake ofsimplicity FIG. 9A and the implant embodiment depicted show of the femurwith opposition to the other surfaces of both knee joints (between femurand tibia, and femur and patella), the areas of contact varyingaccording to activity, forces, and range of motion. Other implantiterations may apply to opposing surfaces.

FIG. 9B depicts a side view of an embodiment of the knee implant 20curved about at least one condyle 22 of a femur 24, the implant 20having appendages 4 b, 4 d extending from an inflated balloon 6. In thisview, the knee is positioned essentially in extension (straight),showing the tibia 36, fibula 38, and patella 40 of the knee. Note thatalthough there would be other joint structures and knee structures in atrue depiction of an implant positioned in the knee, this view of theimplant and bones is greatly simplified for ease of understanding of theimplant and the joint relative (and approximate) positions andplacement. Couplers as described elsewhere herein may be used to couplethe implant 20 to the distal femur 24 and/or the condyle 22 thereof (inthis image the medial condyle, at least since it is primarily a one-sideview of the joint and implant). In FIG. 9B wherein the balloon isinflated, as compared to FIG. 9A wherein the balloon is not inflated oris minimally inflated, the balloon second wall 30 is closer to and/orcontacting the tibial plateau 42 (articular surface) when the balloon 6is inflated. Likewise, FIG. 9C depicts a side view of an embodiment ofthe knee implant 20 curved about at least one condyle 22 of a femur 24,the implant 20 having appendages 4 b, 4 d extending from an inflatedballoon 6 and having couplers 44 a, 44 b (which may be, for non-limitingexample, staples or screws, pins, or snaps) coupling the appendages 4 b,4 d to the femur. In this view, the knee is positioned essentially inextension (straight), showing the tibia 36, fibula 38, and patella 40 ofthe knee. Where the inflated balloon as seen in FIG. 9B may fill inexisting pathologic defects of the joint surface, the medium of inflatedand specific balloon location and durometry with the material of theimplant may also be constructed so as to force the bones opposed, e.g.the femur and tibia, into a more natural limb alignment such as six (6)degrees valgus. However, if the patient being treated has variationsfrom normal in the affected knee as illustrated by examining andmeasuring the opposite normal side, then the implant inflation andpressures or balloon location may be adjusted from the population normsthus customizing this implant to the clinical case under consideration.Fixation devices may be appropriately applied at various knee range ofmotion intervals from full extension (zero degrees) to full flexion(usually 135 degrees) as the knee is adjusted and the implant securedunder anesthesia.

FIG. 10A depicts a side view of an embodiment of the knee implant 20curved about at least one condyle 22 of a femur 24, the implant 20having appendages 4 b, 4 d extending from an inflated balloon 6 andshowing the inflation medium 46 moved anteriorly toward the patella 40when the knee joint is slightly flexed. The dynamic nature of theimplant material and/or content may be responsive to body forces as aphysiological rather than rigid structure. The filling of space insidethe joint may add stability to the patient and to the joint. Likewise,FIG. 10B depicts a side view of an embodiment of the knee implant 20curved about at least one condyle 22 of a femur 24, the implant 20having appendages 4 b, 4 d extending from an inflated balloon 6 andhaving couplers 44 a, 44 b (which may be, for non-limiting example,staples or screws, pins or snaps) coupling the appendages 4 b, 4 d tothe femur 24 and showing the inflation medium 46 moved anteriorly towardthe patella 40 when the knee joint is slightly flexed.

For example, FIG. 14 depicts an embodiment of the knee implant 20 havingappendages 4 a, 4 b, 4 c, 4 d, including holes 8 a, 8 b, 8 c, 8 d andtabs 10 a, 10 b and including slots 26 a, 26 b to accommodate ligamentsof the knee joint as well as side views of the same knee implant.Couplers as described elsewhere herein may be used to couple the implant20 to the distal femur. In some embodiments, there may only tabs, onlyholes, or only appendages, or combinations thereof. In some embodiments,there may be other ways to couple the implant to the distal femur, asdescribed elsewhere herein (sutures, drawstrings, skirts, glue, etc). Insome embodiments, the couplers create the holes 8 a, 8 b, 8 c, 8 d, orother holes (not shown) when the implant is placed against the distalfemur. In some embodiments, the holes are pre-formed in the appendageprior to implantation. In some embodiments, the holes are reinforced asdescribed elsewhere herein. As shown here, the appendages in someembodiments are different in shape and/or size to accommodate thedifferences in condyle size and/or shape. For example the medial condyletends to be larger than the lateral condyle, and thus appendage 4 d thatis intended to wrap over the medial condyle may be longer and/or widerthan the appendage 4 c intended to wrap over the lateral condyle. Shownin the embodiment depicted in FIG. 14 are the different hole placementsfrom the side view, showing the differences in positioning of the holesto accommodate the differences in anatomic structure and size of thecondyles. Likewise, the slots may be different in shape and/or sizeand/or position to accommodate the ligaments and/or tendons of the jointor other structures and functions of the joints of the knee, and toallow for placement of the implant with minimal disturbance (cutting,manipulation, for example) of the joint components such as tendons,ligaments, and other soft or hard tissues. For example, slot 26 a isshaped and positioned to accommodate the cruciate ligaments of the knee,at least. Additionally, as shown in the side views of the embodimentshown in FIG. 14, the implant has a first wall 28 adapted to be adjacentthe femur that is of approximately the same thickness than the secondwall 30. In some embodiments, the first wall 28 is configured to havetherapeutic benefits (pharmacologic, healing, and/or in-growthproperties) as described elsewhere herein. The second wall 30 mayadditionally and/or alternatively be configured to have a therapeuticeffect (pharmacologic, healing, and/or in-growth properties).Additionally, the thickness of the implant in certain locations isvariable to add cushioning to the implant as well as to provide jointspacing. In certain embodiments, the material is not variable inthickness, but provides the same cushioning and/or joint spacing for thebones of the joint. The central region in the embodiment of FIG. 14 isthicker material to add at least one of: cushioning, buffering, jointspace, restore cushioning, and to respond to clinical need.

Any of the balloons described herein with regard to any of the figuresmay add cushioning, padding, strength, durability, flexibility, or anyother aspect noted herein, and need not be a chamber per se, nor beinflatable per se. Rather they are merely distinguishable in certainembodiments from the walls which are on either side of them incomposition or function or both. In some embodiments, the balloon andits interior is not materially different in composition or function fromone of the walls. In some embodiments, they are not materially differentin composition or function from either of the walls.

FIGS. 15A, 15B, and 15C show several views of an embodiment of animplant which has no definable chamber, rather the material of theimplant itself provides the cushion to the bones of the joint (atleast). The implant in 15A, 15B, and 15C is generally H or V-shaped,having a slot 26 b that is significantly smaller than as shown otherembodiments (for example FIGS. 3, 4, 5, 6A, 6B, 7, 14). In certainembodiments, an implant shaped generally like FIGS. 15A, 15B, and 15 cmay comprise a chamber which, if the implant were shown in crosssection, may comprise a different material than the wall of the implantitself, or may be the same material but with different geometric orchemical or physical properties, as noted herein. FIGS. 15A, 15B, and15C depict an embodiment of the knee implant 20 having appendages 4 a, 4b, 4 c, 4 d and tabs 10 a, 10 b, 10 c, 10 d, 10 e, 10 f, 10 g, 10 h andincluding slots 26 a, 26 b to accommodate ligaments of the knee joint.Couplers as described elsewhere herein may be used to couple the implant20 to the distal femur. In some embodiments, there may only tabs, onlyholes, or only appendages, or combinations thereof. In some embodiments,there may be other ways to couple the implant to the distal femur, asdescribed elsewhere herein (sutures, drawstrings, skirts, glue, etc). Insome embodiments, the couplers create holes (not shown) when the implantis placed against the distal femur. In some embodiments, the holes arepre-formed in the appendage prior to implantation. In some embodiments,the holes are reinforced as described elsewhere herein. As shown here,the appendages in some embodiments are different in shape and/or size toaccommodate the differences in condyle size and/or shape. For examplethe medial condyle tends to be larger than the lateral condyle, and thusappendage 4 d that is intended to wrap over the medial condyle may belonger and/or wider than the appendage 4 c intended to wrap over thelateral condyle. The slots may be different in shape and/or size and/orposition to accommodate the ligaments and/or tendons of the joint orother structures and functions of the joints of the knee, and to allowfor placement of the implant with minimal disturbance (cutting,manipulation, for example) of the joint components such as tendons,ligaments, and other soft or hard tissues. For example, slot 26 a isshaped and positioned to accommodate the cruciate ligaments of the knee,at least. The thickness of the implant in certain locations is variableto add cushioning to the implant as well as to provide joint spacing. Incertain embodiments, the material is not variable in thickness, butprovides the same cushioning and/or joint spacing for the bones of thejoint.

FIG. 16 depicts a knee implant embodiment that is generally H orV-shaped, having a slot 26 b that is significantly smaller than otherembodiments, and in this embodiment is effectively replaced with a tab10 i at the same location (e.g. 10 i). FIG. 16 depicts an embodiment ofthe knee implant 20 having appendages 4 a, 4 b, 4 c, 4 d and tabs 10 a,10 b, 10 c, 10 d, 10 e, 10 f, 10 g, 10 h, 10 i and including a slots 26a to accommodate ligament(s) of the knee joint. Couplers as describedelsewhere herein may be used to couple the implant 20 to the distalfemur. Contour lines 54 a, 54 b, for example, are also depicted in FIG.16, however these are not necessarily significant other than to showcontour of parts of the implant 20, although they may be in the casewhere a mesh is provided in the implant. In some embodiments, there mayonly tabs, only holes, or only appendages, or combinations thereof. Insome embodiments, there may be other ways to couple the implant to thedistal femur, as described elsewhere herein (sutures, drawstrings,skirts, glue, etc). In some embodiments, the couplers create holes (notshown) when the implant is placed against the distal femur. In someembodiments, the holes are pre-formed in the appendage prior toimplantation. In some embodiments, the holes are reinforced as describedelsewhere herein. As shown here, the appendages in some embodiments aredifferent in shape and/or size to accommodate the differences in condylesize and/or shape. For example the medial condyle tends to be largerthan the lateral condyle, and thus appendage 4 d that is intended towrap over the medial condyle may be longer and/or wider than theappendage 4 c intended to wrap over the lateral condyle. The slot 26 amay be different in shape and/or size and/or position to accommodate theligaments and/or tendons of the joint or other structures and functionsof the joints of the knee, and to allow for placement of the implantwith minimal disturbance (cutting, manipulation, for example) of thejoint components such as tendons, ligaments, and other soft or hardtissues. For example, slot 26 a is shaped and positioned to accommodatethe cruciate ligaments of the knee, at least. The thickness of theimplant in certain locations is variable to add cushioning to theimplant as well as to provide joint spacing. In certain embodiments, thematerial is not variable in thickness, but provides the same cushioningand/or joint spacing for the bones of the joint. In certain embodiments,an implant shaped generally like FIG. 16 may or may not comprise achamber which, if the implant were shown in cross section, may comprisea several materials which may be the same as or different from any wallof the implant itself, or may be the same material but with differentgeometric or chemical or physical properties, as noted herein.

FIG. 17 depicts a knee implant embodiment similar to FIG. 16 which showsa posterior view including the location(s) 50 a-50 d where a fillmaterial such as cement may be placed. The fill material may be added inany one location 50 a, 50 b, 50 c, or 50 d, or added in several oflocations 50 a, 50 b, 50 c, and 50 d or likewise be added anywhere onthe first or second wall of the implant which contacts the first,second, and/or third bone. The fill material may be used to both cushion(as do balloons 6 in other figures) and/or secure the device to the bonein the case of a bone cement or a combination of these functions. In thecase where the cement is used as the fill material, the cement may beused in an element that may or may not have any, some, or all of tabs 10a-10 i. The cushion, thus can act as a coupler (fixation element) and/oras a cushion and/or spacer for the joint bones. The cushion (whether afill material such as cement or another material) may also be placedadjacent to a first wall or second wall, and not necessarily betweensaid first wall and second wall.

FIG. 18 is an anterior-posterior view of an embodiment of the implant 20attached to a knee model. The implant here comprises chambers 52 a, 52b, 53 c, at least (in this case, nano-inflated air pockets). Althoughsparsely shown in this embodiment, the frequency, size, etc. could beadapted to smaller chambers, larger chambers, more frequent chambers,more concentrated in particular areas of the implant, less concentratedin particular areas of the implant, or similarly adjusted. The chamberscan be diffuse, of any size, containing compressible gas (air), cells,pharmacologics, liquids, beads, metals, or other materials as notedherein.

FIG. 19 depicts an implant 20 which is more squarely cut for interfacewith a femur, for example, which has been cut square such as is done incertain total knee arthroplasty procedures. The implant in thissituation may comprise a polymer alone (of soft or hard durometer)and/or metal. The walls may be contiguous or include a chamber that isoptionally filled or fillable as noted herein. Although tabs are shownin FIG. 19, these are optional in embodiments where another attachmentelement (fixation element) is used such as cement or a metal pin orscrew or snap through an appendage of the device.

FIGS. 20A and 20B depict a knee implant embodiment that is generallyV-shaped or Y-shaped, and in this embodiment the slot 26 b of otherembodiments, or the tab 10 i of other embodiments is effectivelyreplaced with an appendage 4 e at the same location. FIG. 20A depicts anembodiment of the knee implant 20 having appendages 4 c, 4 d, and 4 eand holes 8 a (not shown, in FIG. 20B), 8 b (not shown, in FIG. 20B), 8c (not shown, in FIG. 20B), 8 d, 8 e, 8 f, 8 g, 8 h, 8 i, (not shown,substantially similarly positioned as 8 e on the same edge as 8 a-8 c ofFIG. 20A), 8 j (not shown, substantially similarly positioned as 8 d onthe same edge as 8 a-8 c of FIG. 20A), and including a slot 26 a toaccommodate ligament(s) of the knee joint. Couplers as describedelsewhere herein may be used to couple the implant 20 to the distalfemur through slots 8 a-8 j. Contour lines are also depicted in FIGS.20A and 20B, however these are not necessarily significant other than toshow contour of parts of the implant 20, although they may be in thecase where a mesh is provided in the implant. In some embodiments, theremay only tabs, only holes, or only appendages, or combinations thereof.In some embodiments, there may be other ways to couple the implant tothe distal femur, as described elsewhere herein (sutures, drawstrings,skirts, glue, etc). In some embodiments, the tabs comprise holes. Insome embodiments, the couplers create holes (not shown) when the implantis placed against the distal femur. In some embodiments, the holes arewithin the peripheral rim of the knee implant. In some embodiments, theholes are within the region of the intercondylar notch medially and/orlaterally. In some embodiments, the holes are through the polymer. Insome embodiments, the holes are through a reinforced rim. In someembodiments, the holes are pre-formed in the appendage prior toimplantation. In some embodiments, the holes are reinforced as describedelsewhere herein. As shown here, the appendages in some embodiments aredifferent in shape and/or size to accommodate the differences in condylesize and/or shape. For example the medial condyle tends to be largerthan the lateral condyle, and thus appendage 4 d that is intended towrap over the medial condyle may be longer and/or wider than theappendage 4 c intended to wrap over the lateral condyle. The slot 26 amay be different in shape and/or size and/or position to accommodate theligaments and/or tendons of the joint or other structures and functionsof the joints of the knee, and to allow for placement of the implantwith minimal disturbance (cutting, manipulation, for example) of thejoint components such as tendons, ligaments, and other soft or hardtissues. For example, slot 26 a is shaped and positioned to accommodatethe cruciate ligaments of the knee, at least. The thickness of theimplant in certain locations is variable to add cushioning to theimplant as well as to provide joint spacing. In certain embodiments, thematerial is not variable in thickness, but provides the same cushioningand/or joint spacing for the bones of the joint. In certain embodiments,an implant shaped generally like FIG. 20A or 20B may or may not comprisea chamber which, if the implant were shown in cross section, maycomprise a several materials which may be the same as or different fromany wall of the implant itself, or may be the same material but withdifferent geometric or chemical or physical properties, as noted herein.As shown in FIGS. 20A and 20B, thickness of between the first wall (partconfigured to touch the femur condyle) and the second wall (partconfigured to touch the tibia), is shown for example in the slot 26 a(which may be called a notch herein), thus showing a side wall asdescribed elsewhere herein to provide the thickness to the implant atthe condyle(s). This thickness may be a result of a thickness of amaterial of the implant (as in where the implant comprises a compliantpolymer), or due to an inflation of a balloon that resides between thefirst wall and the second wall and the side wall. In some embodiments,the implant comprises a Dyneema® mesh. The implant may comprise Dyneema®fiber. In some instances, the implant comprises Dyneema Purity® fiber.In some embodiments, the implant comprises a Dyneema Purity® UG fiber.In some embodiments, the implant comprises a Dyneema Purity® VG fiber.The implant may comprise a fiber. The implant may comprise apolyethylene. The implant may comprise a polyethylene fiber.

In all descriptions provided herein of the dual compartment implant, theimplant may instead be configured to couple to or emerge from the tibiaand/or patella. In all descriptions provided herein of the dualcompartment implant, the implant may instead be configured to couple tothe tibia. It is the intention and understanding that the implant issuited for this purpose in certain embodiments with adjustments toaccount for dimensional differences of the tibia. Most descriptionsprovided herein are directed to embodiments coupling the implant to thefemur, however, this is primarily for ease of description andcontinuity, and does not preclude embodiments wherein the implant iscoupled to the tibia. Likewise, as noted elsewhere herein, there areembodiments where the implant may be coupled to two bones (at least),for example to both a tibia and a femur.

Patch

Some embodiments of the implant are configured to repair isolatedlesions wherein osteochondral defects as in osteonecrosis create cratersin the cartilage that need ‘filling in’ with a patch. Various sizelesions of cartilage defects can be accommodated by the implantsprovided herein which may have balloons of at least one of: at mostabout 0.5 cm in diameter, at most about 0.75 cm in diameter, at mostabout 1 cm in diameter, at most about 1.25 cm in diameter, at most about1.5 cm in diameter, at most about 1.75 cm in diameter, at most about 2cm in diameter, at most about 2.25 cm in diameter, at most about 2.5 cmin diameter, at most about 2.75 cm in diameter, at most about 3 cm indiameter, at most about 3.25 cm in diameter, at most about 3.5 cm indiameter, at most about 3.75 cm in diameter, at most about 0.5 cm inlength along the longest length of the balloon, at most about 0.75 cm inlength along the longest length of the balloon, at most about 1 cm inlength along the longest length of the balloon, at most about 1.25 cm inlength along the longest length of the balloon, at most about 1.5 cm inlength along the longest length of the balloon, at most about 1.75 cm inlength along the longest length of the balloon, at most about 2 cm inlength along the longest length of the balloon, at most about 2.25 cm inlength along the longest length of the balloon, at most about 2.5 cm inlength along the longest length of the balloon, at most about 2.75 cm inlength along the longest length of the balloon, at most about 3 cm inlength along the longest length of the balloon, at most about 3.25 cm inlength along the longest length of the balloon, at most about 3.5 cm inlength along the longest length of the balloon, at most about 3.75 cm inlength along the longest length of the balloon, at most about 4 cm inlength along the longest length of the balloon, at most about 4.25 cm indiameter, at most about 4.5 cm in diameter, at most about 4.75 cm indiameter, at most about 5 cm in diameter, at most about 5.25 cm indiameter, at most about 5.5 cm in diameter, at most about 5.75 cm indiameter, at most about 6 cm in diameter, at most about 6.25 cm indiameter, at most about 6.5 cm in diameter, at most about 6.75 cm indiameter, at most about 7 cm in diameter, at most about 7.25 cm indiameter, at most about 7.5 cm in diameter, at most about 7.75 cm indiameter, at most about 8 cm in diameter, at most about 3 cm in lengthalong the longest length of the balloon, at most about 3.25 cm in lengthalong the longest length of the balloon, at most about 3.5 cm in lengthalong the longest length of the balloon, at most about 3.75 cm in lengthalong the longest length of the balloon, at most about 4 cm in lengthalong the longest length of the balloon, at most about 4.25 cm in lengthalong the longest length of the balloon, at most about 4.5 cm in lengthalong the longest length of the balloon, at most about 4.75 cm in lengthalong the longest length of the balloon, at most about 5 cm in lengthalong the longest length of the balloon, at most about 5.25 cm in lengthalong the longest length of the balloon, at most about 5.5 cm in lengthalong the longest length of the balloon, at most about 5.75 cm in lengthalong the longest length of the balloon, at most about 6 cm in lengthalong the longest length of the balloon, 6.25 cm in length along thelongest length of the balloon, at most about 6.5 cm in length along thelongest length of the balloon, at most about 6.75 cm in length along thelongest length of the balloon, at most about 7 cm in length along thelongest length of the balloon, at most about 7.25 cm in length along thelongest length of the balloon, at most about 7.5 cm in length along thelongest length of the balloon, at most about 7.75 cm in length along thelongest length of the balloon, and at most about 8 cm in length alongthe longest length of the balloon. As used herein with respect toballoon dimensions whether length or diameter, the term “about” meansvariations of at least one of 0.1 cm, 0.2 cm, 0.25 cm, 0.5 cm, and 1 cm.

Thus, provided herein is an implant configured to patch osteochondraldefects. The defects may occur due to injury, stress, naturallyoccurring, and/or may created or enhanced by a medical professionalduring a medical procedure. In some embodiments, the implant may becalled a patch having the balloon and an attachment element (orelements—which may be called appendages) described herein and may besized to fit within a defect in a manhole-cover type manner. In someembodiments, the implant may comprise balloon and attachment elementsdescribed elsewhere herein and may be configured to lay over a defect(full defect or partial defect). In some embodiments the implant asdescribed herein as used to patch or repair osteochondral defects may becalled a patch or a patch implant.

In some embodiments, the size of the balloon dimensions are prechosenbased on the individual patient need, and the balloon size (dimensions,geometry, length, depth, for non-limiting examples) is pre-set. In someembodiments, the balloon comprises multiple chambers which may beinflated (or deflated) selectively to fill the defect in situ or justprior to implantation in order to adjust the implant's balloon size(dimensions, length, width, depth, geometry, for non-limiting example)as needed at the time of implantation. The balloon (or any chamberthereof) of some embodiments can be secondarily inflated or deflated (orboth) in situ.

FIGS. 11A, 11B, and/or 11C may be used to describe a patch implantdescribed herein, having appendages 4 a, 4 c, extending from a balloon 6(not shown in FIG. 11A) and including holes 8 a-8 h, and/or tabs 10 a-10f which may be used with couplers (not shown) to couple the implant to abone of the knee joint (which may be the femur, the tibia, or thepatella). Features shown in FIGS. 11A, 11B, and/or 11C are common toboth the unicompartment knee implant (discussed elsewhere herein) andthe patch implant, although dimensions may differ as described herein.Thus, FIGS. 11A, 11B, and/or 11C may be used to describe theunicompartment knee implant and/or the patch implant. FIG. 11A depictsan embodiment of the patch implant 2 curved to simulate curvature aboutone condyle of a femur, the implant 2 having appendages 4 a, 4 c,extending from an uninflated balloon (not shown) and including tabs 10a-10 f and/or holes 8 a-8 h, which may be used with couplers (not shown,described elsewhere herein) to couple the implant 2 to the femur of theknee joint. FIG. 11B depicts an embodiment of the patch implant 2 curvedto simulate curvature about one condyle of a femur, the implant 2 havingappendages 4 a, 4 c, extending from an inflated balloon 6 and includingtabs 10 a-10 f and/or holes 8 a-8 h, which may be used with couplers(not shown, described elsewhere herein) to couple the implant 2 to thefemur of the knee joint. FIGS. 11A and 11B show the appearance of acompliant solid material for unicompartmental implantation. FIG. 11Cdepicts a bottom-up of gliding surface view of an embodiment of thepatch implant 2 curved to simulate curvature about one condyle of afemur, the implant 2 having appendages 4 a, 4 c, extending from aninflated balloon 6 or a padded central area of the implant and includingtabs 10 a-10 f and/or holes 8 a-8 h, which may be used with couplers(not shown, described elsewhere herein) to couple the implant 2 to thefemur of the knee joint. In some embodiments, the implant is configuredto couple to a tibia. In some embodiments, the implant is configured tocouple to a trochlear groove of a femur. In some embodiments, theimplant is configured to couple to only a portion of a condyle of afemur.

FIGS. 12A, 12B, and/or 12C may be used to describe a patch implantdescribed herein, having appendages 4 a, 4 c, extending from a balloon 6and including holes 8 a, 8 b, 8 c prefabricated into an uninflated area,and/or tabs 10 a, 10 b. 10 c, 10 d, 10 e, 10 f which may be used withcouplers (not shown) to couple the implant to a bone of the knee joint(which may be the femur, the tibia, or the patella). Features shown inFIGS. 12A, 12B, and/or 12C are common to both the unicompartment kneeimplant (discussed elsewhere herein) and the patch implant, althoughdimensions may differ as described herein. Thus, FIGS. 12A, 12B, and/or12C may be used to describe the unicompartment knee implant and/or thepatch implant. FIG. 12A depicts a bottom-up view of an embodiment of theimplant 2 (unicompartment or patch), the implant having appendages 4 a,4 c, extending from a balloon 6 and including holes 8 a, 8 b, 8 c, whichmay be used with couplers (not shown) to couple the implant 2 to thefemur of the knee joint. FIG. 12B depicts a bottom-up view of anembodiment of the implant 2 (unicompartment or patch), the implanthaving appendages 4 a, 4 c, extending from a balloon 6 and includingtabs 10 a, 10 b and hole 8 a which may be used with couplers (not shown)to couple the implant to the femur of the knee joint. FIG. 12C depicts abottom-up view of an embodiment of the implant 2 (unicompartment orpatch), the implant having appendages 4 a, 4 c, extending from a balloon6 or padded weight bearing region of the implant and including tabs 10c, 10 d, 10 e, and 10 f and hole 8 a which may be used with couplers(not shown) to couple the implant to the femur of the knee joint. Insome embodiments, the implant is configured to couple to a tibia. Insome embodiments, the implant is configured to couple to a trochleargroove of a femur. In some embodiments, the implant is configured tocouple to only a portion of a condyle of a femur. In some embodimentsthe implant is coupled to the patella. In any embodiment the balloon 6may extend from one surface of the implant as a focal protuberance tofill a defect, space, or to aide in alignment correct, or the balloonmay be full thickness as differences in FIGS. 2 and 3 show respectively.In any embodiment there may be a singular or multiple major balloons, ifoff a primary surface resembling bubble wrap, and there may bemicroscopic balloons or vacuoles containing gas, gel, or solid in thematerial matrix.

In all descriptions provided herein of the patch implant, the implantmay instead be configured to couple to the tibia or to the fibula or thepatella. It is the intention and understanding that the implant issuited for this purpose in certain embodiments with adjustments toaccount for dimensional differences of these bones. Most descriptionsprovided herein are directed to embodiments coupling the implant to thefemur, however, this is primarily for ease of description andcontinuity, and does not preclude embodiments wherein the implant iscoupled to the tibia (or other bones). Likewise, as noted elsewhereherein, there are embodiments where the implant may be coupled to twobones (at least), for example to both a tibia and a femur.

Partial Knee Arthroplasty (Unicompartment)

In addition to the total knee-type (dual condyle) and patch implants areimplants that serve to cover and adjust alignment for either the medialor lateral condyle of the femur with varus or valgus knees requiringadded cushioning to recreate the natural six degrees of knee valgus.

Thus, provided herein is an implant for placement on at least onecondyle of the distal femur (a unicompartment implant—named so due totheir coverage of a single condyle of the femur). The implant may beconfigured to be placed over the lateral condyle. The implant may beconfigured to be placed over the medial condyle. The implant may beconfigured to be placed over either the medial condyle or the lateralcondyle. Two unicompartment implants may be placed in the same knee, oneover the medial condyle, one over the lateral condyle.

FIGS. 11A-12 C depict example embodiments of unicompartment implants. Insome embodiments, the unicompartment implant comprises a balloon that isat least one of: at most about 1.5 cm in diameter, at most about 1.75 cmin diameter, at most about 2 cm in diameter, at most about 2.25 cm indiameter, at most about 2.5 cm in diameter, at most about 2.75 cm indiameter, at most about 3 cm in diameter, at most about 3.25 cm indiameter, at most about 3.5 cm in diameter, at most about 3.75 cm indiameter, at most about 4 cm in diameter, at most about 4.25 cm indiameter, at most about 4.5 cm in diameter, at most about 4.75 cm indiameter, at most about 5 cm in diameter, at most about 5.25 cm indiameter, at most about 5.5 cm in diameter, at most about 5.75 cm indiameter, at most about 6 cm in diameter, at most about 6.25 cm indiameter, at most about 6.5 cm in diameter, at most about 6.75 cm indiameter, at most about 7 cm in diameter, at most about 7.25 cm indiameter, at most about 7.5 cm in diameter, at most about 7.75 cm indiameter, at most about 8 cm in diameter, at most about 3 cm in lengthalong the longest length of the balloon, at most about 3.25 cm in lengthalong the longest length of the balloon, at most about 3.5 cm in lengthalong the longest length of the balloon, at most about 3.75 cm in lengthalong the longest length of the balloon, at most about 4 cm in lengthalong the longest length of the balloon, at most about 4.25 cm in lengthalong the longest length of the balloon, at most about 4.5 cm in lengthalong the longest length of the balloon, at most about 4.75 cm in lengthalong the longest length of the balloon, at most about 5 cm in lengthalong the longest length of the balloon, at most about 5.25 cm in lengthalong the longest length of the balloon, at most about 5.5 cm in lengthalong the longest length of the balloon, at most about 5.75 cm in lengthalong the longest length of the balloon, at most about 6 cm in lengthalong the longest length of the balloon, 6.25 cm in length along thelongest length of the balloon, at most about 6.5 cm in length along thelongest length of the balloon, at most about 6.75 cm in length along thelongest length of the balloon, at most about 7 cm in length along thelongest length of the balloon, at most about 7.25 cm in length along thelongest length of the balloon, at most about 7.5 cm in length along thelongest length of the balloon, at most about 7.75 cm in length along thelongest length of the balloon, and at most about 8 cm in length alongthe longest length of the balloon. As used herein with respect toballoon dimensions whether length or diameter, the term “about” meansvariations of at least one of 0.1 cm, 0.2 cm, 0.25 cm, 0.5 cm, and 1 cm.

In some embodiments, the implant comprises attachment tabs or attachmentelements over the anterior and/or posterior and/or medial side, and/orlateral side (and/or some combination thereof) of a condyle. In someembodiments, the implant comprises attachment tabs or attachmentelements in the intercondylar notch. In some embodiments, the implantcomprises attachment tabs or attachment elements superiorly at thedistal end of the femur anteriorly.

The posterior of the knee can be difficult to access without disturbingjoint components (or in order to minimize such disturbance) such astendons, ligaments, etc. Thus, in some embodiments, the implantcomprises strings, reigns, lassos, and/or lanyards that may pass fromthe posterior of the implant via the intercondylar notch anteriorly tojoin with themselves and/or other coupling devices. In some embodiments,posterior reigns or suture-like lanyards cinch up the implant frominside the posterior intercondylar notch toward another connection sitearound the femur. These couplers may be pre-coupled to the implant, andthe implant and its couplers may be configured to be pulled (or cinched)from the anterior of the implant once the implant is in its generallocation relative to the condyle in order to finally position theimplant about the condyle—in particular in order to cinch the implantabout the posterior of the condyle. Likewise, in some embodiments wherethe implant is pre-molded, the coupler as described are adapted to movethe implant to its final position with conformity to the condyle'sposterior with minimal disturbance to the joint structures at thejoint's posterior (minimal cutting, minimal moving, and or minimaldetachment, for non-limiting example). In some embodiments at least aportion of the ligamentary structure of the knee is spared.

FIG. 10A depicts a side view of an embodiment of the knee implant 20curved about at least one condyle 22 of a femur 24, the implant 20having appendages 4 b, 4 d extending from an inflated balloon 6 andshowing the inflation medium 46 moved anteriorly toward the patella 40when the knee joint is slightly flexed. Likewise, FIG. 10B depicts aside view of an embodiment of the knee implant 20 curved about at leastone condyle 22 of a femur 24, the implant 20 having appendages 4 b, 4 dextending from an inflated balloon 6 and having couplers 44 a, 44 b(which may be, for non-limiting example, staples or screws, pins orsnaps) coupling the appendages 4 b, 4 d to the femur 24 and showing theinflation medium 46 moved anteriorly toward the patella 40 when the kneejoint is slightly flexed.

FIGS. 11A, 11B, and/or 11C may be used to describe a unicompartmentimplant 2 (or unicompartment knee implant, terms which may be usedinterchangeably) described herein, having appendages 4 a, 4 c, extendingfrom a balloon 6 (not shown in FIG. 11A) and including holes 8 a-8 h,and/or tabs 10 a-10 f which may be used with couplers (not shown) tocouple the implant to a bone of the knee joint (which may be the femur,the tibia, or the patella). Features shown in FIGS. 11A, 11B, and/or 11Care common to both the unicompartment knee implant and the patch implant(discussed elsewhere herein), although dimensions may differ asdescribed herein. Thus, FIGS. 11A, 11B, and/or 11C may be used todescribe the unicompartment knee implant and/or the patch implant. FIG.11A depicts an embodiment of the unicompartment knee implant 2 curved tosimulate curvature about one condyle of a femur, the implant 2 havingappendages 4 a, 4 c, extending from an uninflated balloon (not shown)and including tabs 10 a-10 f and/or holes 8 a-8 h, which may be usedwith couplers (not shown, described elsewhere herein) to couple theimplant 2 to the femur of the knee joint. FIG. 11B depicts an embodimentof the unicompartment knee implant 2 curved to simulate curvature aboutone condyle of a femur, the implant having appendages 4 a, 4 c,extending from an inflated balloon 6 and including tabs 10 a-10 f and/orholes 8 a-8 h, which may be used with couplers (not shown, describedelsewhere herein) to couple the implant 2 to the femur of the kneejoint. FIG. 11C depicts a bottom-up view of an embodiment of theunicompartment knee implant 2 curved to simulate curvature about onecondyle of a femur, the implant 2 having appendages 4 a, 4 c, extendingfrom an inflated balloon 6 and including tabs 10 a-10 f and/or holes 8a-8 h, which may be used with couplers (not shown, described elsewhereherein) to couple the implant 2 to the femur of the knee joint.

In some embodiments, the unicompartment implant including attachmenttabs is at least one of: at most about 15 cm in length along the longestlength of the implant, at most about 15.25 cm in length along thelongest length of the implant, at most about 15.5 cm in length along thelongest length of the implant, at most about 15.75 cm in length alongthe longest length of the implant, at most about 16 cm in length alongthe longest length of the implant, at most about 16.25 cm in lengthalong the longest length of the implant, at most about 16.5 cm in lengthalong the longest length of the implant, at most about 16.75 cm inlength along the longest length of the implant, at most about 17 cm inlength along the longest length of the implant, at most about 17.25 cmin length along the longest length of the implant, at most about 17.5 cmin length along the longest length of the implant, at most about 17.75cm in length along the longest length of the implant, at most about 18cm in length along the longest length of the implant, 18.25 cm in lengthalong the longest length of the implant, at most about 18.5 cm in lengthalong the longest length of the implant, at most about 18.75 cm inlength along the longest length of the implant, at most about 19 cm inlength along the longest length of the implant, at most about 19.25 cmin length along the longest length of the implant, at most about 19.5 cmin length along the longest length of the implant, at most about 19.75cm in length along the longest length of the implant, at most about 20cm in length along the longest length of the implant, at most about20.25 cm in length along the longest length of the implant, at mostabout 20.5 cm in length along the longest length of the implant, at mostabout 20.75 cm in length along the longest length of the implant, atmost about 21 cm in length along the longest length of the implant, atmost about 21.25 cm in length along the longest length of the implant,at most about 21.5 cm in length along the longest length of the implant,at most about 21.75 cm in length along the longest length of theimplant, at most about 22 cm in length along the longest length of theimplant, at most about 22.25 cm in length along the longest length ofthe implant, at most about 22.5 cm in length along the longest length ofthe implant, at most about 22.75 cm in length along the longest lengthof the implant, at most about 23 cm in length along the longest lengthof the implant, 23.25 cm in length along the longest length of theimplant, at most about 23.5 cm in length along the longest length of theimplant, at most about 23.75 cm in length along the longest length ofthe implant, at most about 24 cm in length along the longest length ofthe implant, at most about 24.25 cm in length along the longest lengthof the implant, at most about 24.5 cm in length along the longest lengthof the implant, at most about 24.75 cm in length along the longestlength of the implant, at most about 25 cm in length along the longestlength of the implant, at most about 25.25 cm in length along thelongest length of the implant, at most about 25.5 cm in length along thelongest length of the implant, at most about 25.75 cm in length alongthe longest length of the implant, and at most about 26 cm in lengthalong the longest length of the implant. As used herein with respect toimplant length dimensions, the term “about” means variations of at leastone of 0.1 cm, 0.2 cm, 0.25 cm, 0.5 cm, and 1 cm.

In some embodiments, the unicompartment implant is longer than it iswide, and the longer portion of the implant wraps from the anterior ofthe condyle to the posterior of the condyle. In some embodiments, thelength of the implant is longer on the outer edge of the implant than onthe inner edge nearest the trochlear groove (whether used on the lateralor medial condyle). In some embodiments, the trochlear groove per serather than either the medial or lateral compartment is reconstructedwith the implant anatomically to oppose the undersurface of the patella.

FIGS. 12A, 12B, and/or 12C may be used to describe a unicompartment kneeimplant (unicompartment implant) described herein, having appendages 4a, 4 c, extending from a balloon 6 and including holes 8 a, 8 b, 8 c,and/or tabs 10 a, 10 b. 10 c, 10 d, 10 e, 10 f which may be used withcouplers (not shown) to couple the implant to a bone of the knee joint(which may be the femur, the tibia, or the patella). Features shown inFIGS. 12A, 12B, and/or 12C are common to both the unicompartment kneeimplant and the patch implant (discussed elsewhere herein), althoughdimensions may differ as described herein. Thus, FIGS. 12A, 12B, and/or12C may be used to describe the unicompartment knee implant and/or thepatch implant. FIG. 12A depicts a bottom-up view of an embodiment of theimplant 2 (unicompartment or patch), the implant having appendages 4 a,4 c, extending from a balloon 6 and including holes 8 a, 8 b, 8 c, whichmay be used with couplers (not shown) to couple the implant 2 to thefemur of the knee joint. FIG. 12B depicts a bottom-up view of anembodiment of the implant 2 (unicompartment or patch), the implanthaving appendages 4 a, 4 c, extending from a balloon 6 and includingtabs 10 a, 10 b and hole 8 a which may be used with couplers (not shown)to couple the implant to the femur of the knee joint. FIG. 12C depicts abottom-up view of an embodiment of the implant 2 (unicompartment orpatch), the implant having appendages 4 a, 4 c, extending from a balloon6 and including tabs 10 c, 10 d, 10 e, and 10 f and hole 8 a which maybe used with couplers (not shown) to couple the implant to the femur ofthe knee joint.

In all descriptions provided herein of the unicompartment implant, theimplant may instead be configured to couple to the tibia or to thefibula or the patella. It is the intention and understanding that theimplant is suited for this purpose in certain embodiments withadjustments to account for dimensional differences of the particularbones. Most descriptions provided herein are directed to embodimentscoupling the implant to the femur, however, this is primarily for easeof description and continuity, and does not preclude embodiments whereinthe implant is coupled to the tibia (or other bones). Likewise, as notedelsewhere herein, there are embodiments where the implant may be coupledto two bones (at least), for example to both a tibia and a femur.

Meniscal Replacement or Repair, and Solid, Rigid, or Semi-RigidComponents:

Provided herein is an implant having a balloon having a first and secondchamber. The implant may be any of the Dual Compartment, Unicompartment,and Patch implants described herein. The second chamber may beconfigured to replace and/or partially replace fibrocartilage meniscalloss. The implant may have two lobes of chambers which may bealternatively described as two superimposed balloon radii in appositionto each other. The implant may be configured to provide stabilitybetween the femur and tibia by providing a meniscus wedge. In someembodiments the implant comprises a portion configured to replace and/orpartially replace fibrocartilage meniscal loss. Such an embodiment maynot require a second chamber.

In some embodiments a chamber of the implant is configured to receive asolid piece configured to restore joint and/or bone alignment. In someembodiments, the chamber is configured to receive a plurality of solidpieces, each of which can be used to increase the space between a firstbone and a second bone in order to restore and/or improve joint and/orbone alignment. The solid pieces may be wedge-shaped, or be provided invarious sizes and/or shapes. The solid pieces may individually ortogether be used in a chamber or multiple chambers of the implant. Thesolid piece (or pieces) may be used to ratchet adjacent bones to adesired distraction and/or alignment to restore and/or improve jointand/or bone alignment. The solid piece may be put in a chamber of theimplant, which may enclose or partially enclose the piece to hold thepiece in place. In some embodiments, a block of biocompatible material(such as PMMA or another bone-like substitute) may be provided and maybe formed (by carving or other forming method) by the surgeon to adesired shape. The formed piece may then be put in a chamber of theimplant, which may enclose or partially enclose the piece to hold thepiece in place.

In some embodiments, the inflation medium is a methyl methacrylate orother biocompatible hardening substance which can flow when initiallyput into the chamber, and hardens to become a rigid piece (or solidpiece). The methyl methacrylate or other biocompatible hardeningsubstance may conform to the shape of the chamber, or may conform to theshape of a space between bones and/or other joint structures. The methylmethacrylate or other biocompatible hardening substance may conform to aform chosen by the surgeon using tools and/or pressure to influence thefinal shape of the rigid piece formed by the methyl methacrylate orother biocompatible hardening substance upon hardening.

The solid piece (whether formed in situ or by a surgeon or pre-formed)may be cushioned by the implant. The implant may comprise an inflatablechamber between the solid piece and the first bone. In some embodiments,the first bone is a femur. The implant may comprise an inflatablechamber between the solid piece and the tibia. The implant may comprisean inflatable chamber between the solid piece and the patella. Theimplant may comprise an inflatable chamber between the solid piece andthe second bone. The implant may comprise a pad between the solid pieceand the first bone as a cushion. In some embodiments, the first bone isa femur. The implant may comprise a pad between the solid piece and thesecond bone as a cushion. In some embodiments, the second bone is atibia. In some embodiments, the second bone is a patella.

The solid piece may provide at least one of about 1 degree of jointcorrection, about 2 degrees of joint correction, about 3 degrees ofjoint correction, about 4 degrees of joint correction, about 5 degreesof joint correction, about 6 degrees of joint correction, about 7degrees of joint correction, about 8 degrees of joint correction, about9 degrees of joint correction, and about 10 degrees of joint correction.With respect to degrees of joint correction, the term “about” can meanranges of 1%, 5%, 10%, 25%, or 50%.

The implant can be used in a variety of joints where the implantreplaces a bone on bone surface and cushions the interaction between thearticular ends of any two bones, such as at the femoral tibial andpatella femoral knee interfaces. The implant can be used in a variety ofjoints where the implant replaces a bone on bone surface and cushionsthe interaction between the articular ends of any two bones, such as atthe femoral-acetabular interspace of a patient's hip, the humerus andglenoid scapular component in the shoulder, the replacement of talusbone in the human ankle between the tibia and calcaneus and the like.Where the implant is substituting or enhancing articular cartilage, therigidity can be reduced or enhanced to maximize conformation changesthat arise during motion as enabled by the two opposing walls andintended inner space, coupled with considerations in any joint surgicalreconstruction with accommodation to or amplification of the existingjoint ligaments, tendons or dearth thereof. The implant 10 may bedeflated and removed by minimally invasive surgery, for example, afterthe implant has served its purpose of regenerating tissue or if anotherclinical condition warrants its removal. However, it may not beclinically necessary to remove the implant even if inflation is lost,since the two remaining functions of patching the injured cartilage, anddelivering restorative cells may justify implant retention.

In many embodiments the implant (or a portion thereof, such as theballoon or balloon) is a weight bearing spacer that allows joint motionsto approach normal, whether filling the space left by an entirelycollapsed peripheral joint bone or the space of ablated cartilageproximate surfaces diffusely as in osteoarthritis or succinctly as inosteonecrotic defects or localized trauma. The walls may be used as amembrane for holding living cells in proximity of the osteochondraldefect long enough for the cells to attach (e.g. 24 hours) or to deeplyadhere (up to 28 days) or return to normal (up to one year). Weightbearing may be expected to increase as distal lower extremity joints aretreated.

Additional Locations for Use

Shoulder subacromical bursa may be a target joint for an implant asdescribed herein. Rotator cuff tears may be addressed using an implantas described herein—as adjusted for the particular features, loadingprofile, and geometries of the joint. In shoulders, 85% of octagenianshave massive rotator cuff tears and often less than half normal upperextremity abduction and flexion capabilities. There may not besufficient remnant supraspinatus and other rotator cuff tissues to pulltogether. Then the humeral head rides up, in a cephalad direction,rubbing the superior bone surface on a frequently spurred and downwardsloping acromion. If a subacromial implant as described herein wereimplanted beneath the lateral (arthroscopically decompressed andprepared) acromion, the pain of bone on bone could be reduced, and thestructural anatomy between the ball and socket (humeral head and glenoidfossa) could be improved. In essence then a shoulder implant could coverthe humeral head analogous to the hip redundant membrane wherein thatmembrane replaces a normal subacromial bursa. Optionally, a singularbladder beneath the acromion per se could pad the ball beneath it. Forvirtually every joint in the body (arms and legs, at least) there aresimilar potential implant uses.

The distal femur of the knee, and the distal humerus of the elbow areregions that interface each with two opposite joints. That is, animplant for the knee as designed with polymer capping of the femoralcondyles and trochlear groove to provide cushioning of the femorotibialand patellafemoral joints. Analogously, in the humerus the distalcoverage enables padding restoration of the humeral-olecranon as well asthe radio-capitellar (part of the humerus) joint interfaces. Whereasgenerally the implant may cover the main or primary joint surface of thesurgeon's choice contributing to arthritis, consequently reducingsymptoms when treated, another alternative would be that the implant cancover any singular surface entirely or partially. It is generallydesired that the implant may cover one surface allowing remnantcartilages in other usually opposing or opposite surfaces to glideagainst the implant polymer with smooth gliding joint motion. Thisprinciple allows for retained joint linings or synovium to producelubricating substances including enzymes for facile joint movement. Italso avoids the wear debris that would accrue from polymer rubbing onpolymer, as recently recognized in metal on metal prostheses. In certainembodiments, the implant can cover more than one surface in a joint,such as the radiocapitallar joint wherein the distal humerus and theradial head receive prosthetic capping or interpositional application ofpolymers.

The surgical techniques may be individualized to fit patient need. Theimplants may be combined with or comprise autologous or allographtissues such as fascia lata. Surgeons may implant fascia lata aboveunreconstructable rotator cuff with consequent symptom relief. Polymerscan interface with any human tissue and/or with metals or polyethylenesor polyurethanes. Living tissues that can be combined with implantsprovided herein for repair or reconstruction may be from the samepatient (autograph), and cadaver or other member of the same species(allograph) or from another species (xenograph.) Virtually anycombination of polymer interpositioning is feasible with the implantconcepts provided herein, as anatomy varies among patients in need, andclinical conditions differ with each person. Therefore, although thegeneral or most common construct is expected to cover just one singularand the primary surface of a joint with an implant, any combination ofsurfaces can be involved allowing versatile custom applications of thisimplant and method of surgery.

Additionally, whereas implants as noted herein may be available inspecified sizes, the material membrane elastic deformation andresilience may allow for calculated malleability toward goodness of fit.In other iterations the fit of implant over the affected joint surfaceis customized as paring preoperative findings of MRI or CT or PETimaging pathophysiology with intraoperative reconstructive need.Ultimately best fit implants may serve patient restorative requirementwith least morbidity.

Locations wherein implants described herein may be additionally oralternatively applicable include all the limb joints of mammals. In theshoulder mainly the glenohumeral joint, though as discussed above thesubacromial space are useful loci for renewed padding whenpathophysiologies warrant. In the AC or acromioclavicular joint of theshoulder, a Mumford procedure (resection of the distal clavicle) can beavoided by inserted an implant as described herein. Even the TMJ in thejaw may be amenable to therapy using the implants noted herein.Proceeding distally in the aim, the elbow has two relevant jointsmentioned earlier, radiocapitellar and ulnohumeral. Depending on ‘wherethe arthritis forms’ (as from fracture or disease) the padding should berestored toward normal. Wrist, thumb and finger joints are many and mayrespond to vesicular implants with better durometry and vicsolubricantdelivery than tradition metal or silicon prostheses. Legs started at thehip joint have been shown via Hip implant prototypes to be amenable topolymer capping. Variations per surgeon's choice could evoke specialuses as for coverage of trochanteric bursae.

Additionally, the many functions of the implants noted herein may becoupled with cosmetic aspects in order to restore bulk and soft tissuebalance after scarring, injury or atrophy, or for purely cosmeticpurposes. Treatment for cosmesis especially when coupled with functionalor visual injury deficits can provide a reduction in physiological aswell as physical pain and discomfort. Therefore the extent minimallyinvasive implants restore the injured or diseased patient recipient tobecome hole, they are being used purposefully and as intended.

The knee joint is an initial focus of the figures wherein application tothe largest bone (the distal femur) accommodates padding needs for theopposing patella and tibia. The potential use of implants, however, overthe contralateral surfaces is an option that should not be ruled out. Inthe ankle the supratalar, or tibia talar joint will be a useful locationas may the subtalar area, depending on pathology present. Indicationsfor use may depend on the patients symptoms, from the history andphysical exam, based on studies such as roentgenograms, MRI or CTimaging, and may depend on test result from localized injections. Forexample, if a talus fracture pain were alleviated by sinus tarsiinjection then implant insertion into the subtalar joint would bepreferred. The talonavicular and other foot/toe joints are all amenableto renewed padding via an implant noted herein.

Pets, or other animals, such as cows, dogs, and horses, may be servedbetter by polymer joint capping than hip replacement for congenitaldysplasia. The successful treatment and rehabilitation of animals canfavorably affect the implant recipient and animal's owner, as pets canprovide functions necessary for activities of daily living (as a horsehelping to plow a field) or an animal relieved of pain from injury orarthritis can also be a comfort to its owner.

Kits

Provided herein are kits comprising multiple implants described herein.A kit may comprise multiple sizes of a single type of implant. A kit maycomprise various implant types, such as the patch, the unicompartment,and/or the dual compartment types of implants described herein. A kitmay comprise various couplers, which may be selected by the surgeondepending on his comfort and expertise, and/or based on the particularpatient anatomy and/or needs. The kit may further comprise any insertiontools and/or surgery tools that may uniquely assist in implanting theimplant in the patient.

In addition to kits involving reparative implants, and insertionaltools, there may also be included software for translation of pre-injurydata and/or postoperative data collection and analysis, as well ascustom implants may be provided.

Implantation Methods

Implantation of implants provided herein may depend on the size of jointsurface intended for reconstruction by use of the implant. This may bebased upon the nature and extent of injury, and upon the expectations ofthe patient and surgeon. In some embodiments, an arthroscope can beinserted in one side of the knee joint through a 0.5 cm wound, while theimplant is inserted into the opposite joint line wound from 1-10 cm insize. The joint may be first inspected and debrided, performing anarthroscopic synovectomy, chondroplasty, and meniscectomy as needed.Additional distraction under general anesthesia with the knee atvariable degrees of flex may allow for implant introduction, systematicperipheral attachment, balancing, and inflation, if warranted.

In some embodiments, the implant may be selectively inflatable dependingon the particular needs of the patient. In some embodiments, the fillerof the interior of the implant may be rigid, semi-rigid, fluid, air, orcombinations thereof, as described herein. In some embodiments, theimplant may be used in conjunction with fibrocartilage repair orreplacement. In some embodiments, the implant may be used withoutfibrocartilage repair or replacement. In some embodiments, the implantmay be used in conjunction with boney osteotomy. In some embodiments,the implant may be used without boney osteotomy.

The posterior of the knee can be difficult to access without disturbingjoint components (or in order to minimize such disturbance) such astendons, ligaments, etc. Thus, in some embodiments, the method comprisesproviding an implant comprising strings, reigns, lassos, and/or lanyardsthat may pass from the posterior of the implant via the intercondylarnotch anteriorly to join with themselves and/or other coupling devices.In some embodiments, posterior reigns or suture-like lanyards cinch upthe implant from inside the posterior intercondylar notch toward anotherconnection site around the femur. In some embodiments, the methodscomprise conforming the implant posterior to the condyle by pulling thestrings (or reigns, or lassos, or lanyards or the like) of the implant.Such couplers (strings, reigns, lassos, lanyards, etc) may comprisesuture materials and/or wire materials.

These couplers (i.e. strings, reigns, lassos, lanyards, etc) may bepre-coupled to the implant, and the implant and its couplers may beconfigured to be pulled (or cinched) from the anterior of the implantonce the implant is in its general location relative to the condyle inorder to finally position the implant about the condyle—in particular inorder to cinch the implant about the posterior of the condyle. Likewise,in some embodiments where the implant is pre-molded, the coupler asdescribed are adapted to move the implant to its final position withconformity to the condyle's posterior with minimal disturbance to thejoint structures at the joint's posterior (minimal cutting, minimalmoving, and or minimal detachment, for non-limiting example). In someembodiments at least a portion of the ligamentary structure of the kneeis spared.

In some instances, the implant is inserted arthroscopically through acannula about 10 mm in diameter with the implant in the deflatedconstruct, and once inside the prepared joint space and secured thereinby the skirt or tabs, the implant is distended or inflated with gas,gel, fluid or fluid that becomes a resilient solid to fill the originalnatural space of about 0.5 cm between the bones of the joint (between atleast two bones of the joint). If the implant is not inserted through acannula, it may be inserted through an open incision from one to fortycentimeters in length at the surgeon's discretion. Tensioning may be bythe surgeon's sense of proper pressure application aided by a gaugedsyringe for insertion of viscolubricants such as Synvisc, Hyalgan,Supartz and/or analgesics such as lidocaine gel. The insertion ofliquids to the joint per se may be directly, through a cannula to thejoint space previously in place for debridement, and or via a cannula ortube that is not part of the original implant assembly. Once the jointis cleaned, the implant is inserted and appropriately fixed to avoidextrusion or dislocation thereof. This may be via attachment of theimplant tabs and/or by a combination of tab use plus intended frictioncreated by implant surface coverings (analogous to Velcro) or a drawstring at the smaller base of the implant.

In some embodiments the attachment tabs are positioned on the implant toboth secure the implant to the joint components, and to enable aphysician to ensure the implant has a minimum amount of slack that couldcreate wrinkles or loose areas to avoid unnecessary friction and/or wearof the implant of the patient's anatomy. Figures depicted herein showexamples of properly situated attachment tabs configured for these dualpurposes. In some embodiments, fewer tabs are needed to achieve thesegoals.

In some embodiments, where slack or voids exist, the balloon undercompression may fill such areas. The implant in some embodiments isconfigured to allow hyaline and/or cartilage cells to fill anyirregularities or craters in the joint components and grow to refurbishnatural joint contour. When the implant implantation is combined with,for example, movement of the treated joint in a constant passive motionmachine for 12 hrs a day for 6 weeks after surgery implanting theimplant, cell growth may create renewed hyaline cartilage, and/orblood/fibrin and scar to create fibrocartilage filler material.

Each attachment tab insert site may be clinically determinedcentripitally around the implant during surgery, driving slots or holessequentially with an osteotome or drill immediately followed byinsertion of the triangled tab extension into the bone slots or screwrespectively. For example, if the implant were viewed like a clockfacethe first tab could be tacked/tapped in a 2 o'clock, then 7, 10, 4, 11,5, 12, 6 (wherein #2, 7, 10, 4 are over the bilateral femurssuperior/inferior to collateral ligaments, 11, 12 are superior at thedistal anterior femur beneath the upper patella, and 5, 6 are inside theintercondylar notch anterior to cruciates). This can be like putting asaddle on a horse, going around the knee end with a grasper, to tug thepolymer toward fit, tapping a slot over the side of the femur with athin one-half inch osteotome, angling cuts distally, one by one, as ifto pull the implant (or saddle) into its angle of repose, seatingideally over the condyles and ridings nicely in the trochlear groove.

In some embodiments, the metal clips could be set angled at about 120degrees, as greater than 90 can favorably distract/hold the implant totighter fit analogous to a mylar compliant balloon or stretch sockfitting over a protuberance as opposed to a piece of (non-compliant)paper that results is wrinkles and areas of incongruence between theimplant and bone end. Reducing dislodgement tendency and snugging thepolymer once stretched to best fit may avoid the failure history asillustrated in the Danish Polymer hip cap solid crescent shaped hipresurfacing implants which lacked inflation, surface stability,accommodation, and fixation.

Inflation may also be specified by clinical need, and modifications inthe implant multi-cell (multi-compartment) construction allows forselective inflation with substances ranging from gas to solid, includinggels or semi-solids that can as part of material layered integrityeither provide calculated hardness (durometer) to overcome and resistlimb adjacent bone mal-alignment, and/or to deliver new regenerativetissues for restoration of natural anatomy of time. That is, certainsections of the implant may be electively inflated of left withoutexpansion, to adjust to fit as matching a normal or uninjuredcontralateral limb for the involved patient.

Indeed, patient interaction and feedback may be sought so as to bring toorthopedic conceived art and science the individual's own needs andconcerns. It is said that for patients who have anterior cruciateinjuries, one third require reconstruction for knee joint stabilizer,one third do not—living with a reduced activity level, and one thirddeliberate extensively until a choice between the two continuum optionsis made.

A goal of embodiments of implants described herein is to maintainremnant living tissue by using minimally invasive technologies, smallerincisions when they serve the patient equally to larger, sacrificing theleast normal tissue as possible. Implants described herein assist andimprove on current treatment options available by avoiding as much aspossible the ablative bone and cartilage resecting, ligament removingtotal knee arthroplasty and instead to restore the padding lost ininjury or disease or surgery.

Examples from within the techniques include electing to repair ratherthan reconstruct anterior cruciate ligaments in certain situations,proved warranted and effective at a p<0.3 statistical level. WhereasCarticel chondrocyte implantation is useful to enable articular surfaceregrowth with hyaline, rather than scar/fibrocartilage frompicking/drilling, the massive morbidity from periosteal harvesting isunnecessary. This is because it takes only 24 hours for the cartilagecloned chondrocytes to attach to the prepared joint surface, and thepolymer membrane (patch implant described herein, for example, or use ofchondrocytes on surfaces of the dual compartment implant or theunicompartment implant) over the prepared defect (like a manhole cover)can adeptly substitute for periosteum.

With these concepts in mind in is the overall intent to do what isnecessary to restore function and nothing more in order to spare thepatient removal of injured tissues that may recover or regrow, byimplementing a common sense approach to limb repair and reconstructionwith the implant and methods of use thereof. In animals as horses anddogs, where recovery instructions are even less likely to be followedthan with humans, implanting secure restorative implants for jointsurface refurbishment may offer renewed function and save lives thatwould have otherwise been sacrificed.

Rehabilitation of knee implant treated patients may engage prudent earlymotion. The amount of weight bearing allowed may be analogous to theprocedures written by this primary surgery for Carticel implanted cases,following the principles that excessive amounts and repetitions ofstress upon reconstructed areas should be avoided for 6-12 weeks aftersurgery. However, the knee implant surgeries per se are expected to takeless than one hour, involve less than 1 cc blood loss, require woundsless than or equal to 10 cm overall (depending on the embodiment of theimplant), and the end result intends to permit early full weightbearing. Zealous sports activities may be restricted until the bonein-growth and cartilage renewal is reasonably expected, between 2 and 12months after surgery depending upon the amount of joint tissue replaced.

In some situations, the removal of the implant may be needed, andembodiments of the implants described herein are configured for removalarthroscopically, and with the allowance to perform all regular olderroutine accepted techniques ranging from joint debridement to drilling,partial or total replacement. In some embodiments the implant isconfigured for removal and replacement with a replacement implant—eitherimmediately (within a week), or after a period of longer time (forexample, after about 6 weeks to 1 year in the case of infection once allforeign bodies are removed and depending upon the surgeon's and/orinfectious disease consultant's opinion

Specific surgical decisions related to size matching, fixation and orconcomitant osteotomy warranted reconstruction are left to the primarysurgeon and patient in each case.

The implant is inserted by minimally invasive surgery, in someembodiments; however, in other embodiments, the implant may not beinserted by minimally invasive surgery. In some embodiments, the implantis delivered through an incision that is about 0.5 inches long. In someembodiments, the implant is delivered through an incision that is about1 centimeter long. In some embodiments, the implant is delivered throughan incision that is at most about 1 inch long. In some embodiments, theimplant is delivered non-arthroscopically through an incision that is atleast 1 centimeter long. In some embodiments, the implant is deliveredthrough an incision that is at most about 0.75 inches long. In someembodiments, the implant is delivered through an incision that is atmost about 0.5 inches long. In some embodiments, the implant isdelivered through an incision that is about 8 centimeters long. In someembodiments, the implant is delivered through an incision that is about9 centimeters long. In some embodiments, the implant is deliveredthrough an incision that is about 10 centimeters long. In someembodiments, the implant is delivered through an incision that is about11 centimeters long. In some embodiments, the implant is deliveredthrough an incision that is about 12 centimeters long. In someembodiments, the implant is delivered through an incision that is overabout 10 centimeters long. In some embodiments, the implant is deliveredthrough an incision that is at up to about 40 centimeters long. In someembodiments, the implant is delivered through multiple incisions. Insome embodiments, the implant is delivered non-arthroscopically. Inother embodiments, the implant is delivered arthroscopically. Withrespect to incision length, the term “about” can mean ranges of 1%, 5%,10%, 25%, or 50%.

In some embodiments the implant is configured to be delivered to thejoint arthroscopically. In some embodiments, the implant is configuredto fit within a cannula having a distal end inner diameter of at mostabout 10 millimeters. In some embodiments, the implant is configured tofit within a cannula having a distal end inner diameter of at most about9 millimeters. In some embodiments, the implant is configured to fitwithin a cannula having a distal end inner diameter of at most about 5millimeters. With respect to cannula distal end inner diameter, the term“about” can mean ranges of 1%, 5%, 10%, 25%, or 50%.

In some embodiments, the implant is configured to fold in order to fitwithin a cannula having a distal end inner diameter of at most about 10millimeters. In some embodiments, the implant is configured to fold inorder to fit within a cannula having a distal end inner diameter of atmost about 9 millimeters. In some embodiments, the implant is configuredto fold in order to fit within a cannula having a distal end innerdiameter of at most about 5 millimeters. With respect to cannula distalend inner diameter, the term “about” can mean ranges of 1%, 5%, 10%,25%, or 50%.

In some embodiments, the implant is configured to be delivered to ajoint through a cannula having a distal end inner diameter of at mostabout 10 millimeters. In some embodiments, the implant is configured tobe delivered to a joint through a cannula having a distal end innerdiameter of at most about 9 millimeters. In some embodiments, theimplant is configured to be delivered to a joint through a cannulahaving a distal end inner diameter of at most about 5 millimeters. Withrespect to cannula distal end inner diameter, the term “about” can meanranges of 1%, 5%, 10%, 25%, or 50%.

In some embodiments the implant may be provided as a deflated balloonfor insertion into the joint space. In some embodiments the implant maybe provided as folded balloon that may be collapsed like an umbrella forinsertion into the joint space. In some embodiments the implant may beprovided as collapsed balloon that is of an irregular folded pattern tominimize its folded (or collapsed) size for insertion into the jointspace. In some embodiments, the implant is configured to blow up (orexpand) to take the form of the expanded, distracted, debrided joint.

In some embodiments, the implant replaces periosteum.

In some embodiments, the implant is implanted to preserve bone ascompared to a typical arthroplasty procedure of the joint. In someembodiments, the implant is implanted to preserve cartilage as comparedto a typical arthroplasty procedure of the joint. In some embodiments,the implant is implanted with minimal soft tissue dissection as comparedto a typical arthroplasty procedure of the joint. In some embodiments,the implant is implanted without joint dislocation. In some embodiments,once implanted, the joint is adaptable to revision surgery. In someembodiments once implanted, the joint retains at least one of: about 90%of normal joint function, about 95% of normal joint function, about 85%of normal joint function, about 80% of normal joint function, about 75%of normal joint function, about 70% of normal joint function, about 65%of normal joint function, about 60% of normal joint function, about 55%of normal joint function, about 50% of normal joint function, at least95% of normal joint function, at least 90% of normal joint function, atleast 85% of normal joint function, at least 80% of normal jointfunction, at least 75% of normal joint function, at least 70% of normaljoint function, at least 65% of normal joint function, at least 60% ofnormal joint function, at least 55% of normal joint function, at least50% of normal joint function, about 50%-about 75% of normal jointfunction, about 50%-about 70% of normal joint function, about 60-about70% of normal joint function, about 70%-about 80% of normal jointfunction, about 70%-about 90% of normal joint function, about 80%-about95% of normal joint function, about 80%-about 90% of normal jointfunction, and about 90%-about 95% of normal joint function. As usedherein with respect to percentage of normal joint function, the term“about” can be ranges of 1%, 5%, 10%, or 25%. For example, a range of 1%with respect to about 90% of normal joint function covers 89% to 90% ofnormal joint function.

In an example of a hip implant, an upper portion of the implant has afirst wall, a second wall and a side wall which define at least in partthe interior. A skirt depends from the first wall and secures the firstwall to the end of the patient's femur. An upper portion may beconfigured to engage the corresponding acetabulum of the patient'spelvic bone. The skirt surrounds the head of the patient's femur andsecures the implant thereto. In this embodiment, the upper portion ofthe implant creates overlapping layers, like a redundant membrane, inthe side wall between the first and second walls and to accommodate thenormal movement of the first or second. This provides greater motionbetween the femur and the acetabulum and also provides implantstabilization over the head of the femur. This structure alsoaccommodates variation in individual joints that occur from patient topatient.

In an embodiment, the first wall does not extend across the entire endof the patient's femur. However, the implant may be designed so thatfirst wall may extend over the head of the femur. The second wall andthe side wall tend to roll as the femur moves within the acetabulum.

In some embodiments, prior to deploying the implant embodying featuresof the invention, the cartilage lining the joint is prepared by removinghyaline or fibro cartilage flaps or tears, and areas of chondraladvanced fissuring are excised or debrided to create precisely defineddefects surrounded by stable normal remnant hyaline cartilage withvertical edges in relation to the damaged surface. It is these defectsof the cartilage previously normal surface into which new living cellsmay be injected or otherwise inserted, and allowed to aggregate by theimplant interpositional arthroplasty proximate expanded compressiveexternal wall material. Synovitis invading the joint periphery may bevaporized and extracted conventionally or by the use of steam. Areas ofgreater cartilage damage are removed for subsequent regeneration and theless afflicted areas having stable cracks are treated to seal or weldthe cracks. Areas where the tugor or consistency or minimally damagedcartilage can be preserved are intentionally saved rather than destroyedso as to support the normal spacing and gliding opportunity of the morenormal joint interface. Thus, normal cartilage is left behind andabnormal cartilage is removed with the implant making up for thedeficiencies. With the present invention, it is preferred in someembodiments to avoid joint dislocation so as to preserve naturalinnervations and vascularity and thus preserving the blood supply.

Joint preparation is usually performed under a brief general anestheticof outpatient surgery. A muscle relaxant combined with traction (e.g. 60pounds force for a hip implant) may be employed to opens the joint widerto permit improved visualization for joint preparation and implantinstallation, increasing the space between the remnant cartilage fromabout 3 up to about 12 mm. Increasing the joint space may be necessaryand allows the surgeon to wash out noxious enzymes, to remove invasivesynovitis, to remove loose bodies, to prepare osteochondral defectsideally and otherwise prepare the joint for the implant. Partial orcomplete inflation of the implant may precede release of traction insome embodiments. In some embodiments, regeneration agents or cells areinserted with the implant or as a fluid or 3-D template prior to releaseof traction and wound closure. It is preferred, in some embodiments, toperform joint debridement, implant deployment and application of cellregeneration agent, e.g. stem cell application, under the sameanesthetic. As described by several companies in the Stem Cell Summitheld in New York, N.Y. on Feb. 17, 2009, it is desirable to obtain anaspiration of the patient's bone marrow from the iliac crest afteranesthesia sterilely at the beginning of the operation. Theintraoperative technologist may “dial in the cells” to regenerate areasof maximum pathophysiology while the surgeon debrides or otherwiseprepares the joint and inserts the implant, placing the cells at thebest time. Cell implantation may also occur as a secondary or tertiaryreconstructive treatment adjunct. An example resilient implant may bedeployed within a patient's hip structure comprising the head of thepatient's femur and the acetabulum of the patient's pelvic hip bone. Theresilient implant embodying features of the invention is disposed withinthe space between the femur and the acetabulum. The implant is shapedlike a half an orange rind or a hemisphere for a hip joint. The implanthas a first wall which is secured to the head of the femur by aplurality of depending tabs (or appendages). The tabs may be attached tothe femur by a suitable adhesive or mechanically such as by a screw orpin or snap. The second wall the implant engages the acetabulum, but italso may be provided with tabs and the like for securing the second wallthe acetabulum.

The side wall extends between the first and second walls to form aninterior which receives filling material through tube (also called aconduit herein, or may be called an inflation port). The implant wouldalso be appropriate for the humeral head in the shoulder or one condyleof the knee or of the humerus, but other shapes may be desired for otherjoint configurations whether relatively flat as in the thumb base, ormore inflated toward a ballooning construct as in the ankle when thetalus bone is collapsed.

In many embodiments the implant (or a portion thereof, such as theballoon) is a weight bearing spacer that allows joint motions toapproach normal, whether filling the space left by an entirely collapsedperipheral joint bone or the space of ablated cartilage proximatesurfaces diffusely as in osteoarthritis or succinctly as inosteonecrotic defects or localized trauma. The walls may be used as amembrane for holding living cells in proximity of the osteochondraldefect long enough for the cells to attach (e.g. motion is believed tobe primarily between the spaced walls (or portions) of the implantperipherally secured to joint structures, although some motion may occurbetween the implant and the joint surfaces (as with current bipolar hiphemiarthroplasties)). The implant may be provided with a slot extendingfrom the periphery of the implant to a centrally located passage throughthe implant to accommodate the ligament of the head of the femur for hipimplants. Knee implants may have two slots leading to separate passagesfor receiving the anterior and posterior cruciate ligaments. Implantsfor other locations may have similar variable structures to accommodateanatomical features. Implant walls should have sufficient inherentflexibility to mold to the existing deformities imposed by eithernatural ligament, bone, tendon or remaining cartilage deformities of theinternal joint space, and thus filled as a cushion. A separate portal ortube (not shown) or the existing conduit (tube or valve), may be used toextract noxious inflammatory enzymes that can be aspirated atappropriate clinical intervals. Viscolubricants can be injected into theinterior of the resilient arthroplasty device through existing conduitor through a long needle to aide in distension, expansion, and/orlubrication (with predetermined microporosity).

The ankle version of the arthroplasty implant of the present inventioncomprises a square transverse cross-section that must take into accountsupratalar ankle dorsi/plantar flexion, subtalar eversion/inversionmotions, ligament fixation-needs, and the accommodation to existing bonyarchitecture as implant variables accounting for the ipsilateral jointpathophysiology. The implant has a first wall, a second wall and a sidewall which extends between the first and second wall. The exterior ofthe implant may have a mesh material with a plurality of chords (orappendages) for securing the implant to adjacent bones or to remnantligaments which are attached to adjacent bones.

The implant may be inflated with gas and/or liquid to open wider thespace between the tibia above and the calcaneus below to accommodatecollapse of the talus bone as in the flattening which succeeds talusfracture with avascular necrosis, or it may be filled with a liquid thatbecomes a resilient solid. The instant center of the implant's rotationwill be constantly changing, with the talus implant mainly stable andwith the tibia moving over it. Deformation with weight bearing duringthe average human's 10,000 daily steps or 2-4 million annual gait cyclesrequired by the stance and walking of normal activities of daily living,must be balanced between sufficient solidarity of the implant tomaintain axial load, avoiding circumferential stress, and shear forcesimposed by the tibia distal plafond on the dorsal ankle implant allowingstance and gait of the patient while avoiding implant migration orfailure. Further accommodation to lateral forces imposed by the boneymedial and lateral malleoli need to be endured through the cyclic loadof walking, while collapsing with enough give to absorb shock and tomatch the shape of surrounding structures of bone and ligament tissue.Whereas the axial load between the distal tibia through the talarimplant to the dorsal calcaneus may be loaded during stance andespecially while walking on a level plane for supratalar motion, thelateral forces may be loaded particularly with subtalar motion whilewalking on an uneven plane or with inversion/eversion.

In some embodiments, the first inflation medium imparts rigidity in theimplant. In some embodiments, the first inflation medium imparts cushionin the implant. In some embodiments, the inflation medium chosen for thefirst inflation medium, and/or the particular choice of chamber (inembodiments having multiple chambers) filled with such first inflationmedium aligns the joint. In some embodiments, the inflation mediumchosen for the first inflation medium, and/or the particular choice ofchamber (in embodiments having multiple chambers) filled with such firstinflation medium aligns the bones of the joint. In some embodiments, theinflation medium chosen for the first inflation medium, and/or theparticular choice of chamber (in embodiments having multiple chambers)filled with such first inflation medium changes the bone alignment. Insome embodiments, the inflation medium chosen for the first inflationmedium, and/or the particular choice of chamber (in embodiments havingmultiple chambers) filled with such first inflation medium improvesjoint alignment. In some embodiments, the inflation medium chosen forthe first inflation medium, and/or the particular choice of chamber (inembodiments having multiple chambers) filled with such first inflationmedium restores, at least in part, joint alignment. In some embodiments,individual chambers of the interior are selectively inflated with afirst inflation medium and/or a second inflation medium. In someembodiments, individual chambers of the interior are selectivelyinflated with a first inflation medium and/or a second inflation mediumin order to reconstruct the joint and/or bones of the joint.

In some embodiments, the interior comprises a honeycomb structure. Insome embodiments, the interior comprises a mesh structure. In someembodiments, the interior comprises a sponge structure.

The dimensions of the various implant walls may vary depending upon thematerial properties thereof as well as the needs for a particular joint.The spacing between the first and second wall within the interior canvary from about 0.5 mm to about 5 mm for most joints (except for theimplant for an ankle when an entire collapsed bone space is beingreplaced), preferably about one to five centimeters to fill between thetibia and calcaneus. In the ankle invention version of the implant, theamount of inflation of the implant per se may be directly proportionalto the amount of talus bone collapse between the distal tibia andproximal calcaneus—thus as much as 5 cm implant distension or expansionmay be required to be maintained between superior and inferior surfacesof the talus, while as much as 10 cm anterior and posterior expansionmay be required for the ankle implant between the posterior soft tissuessuch including the Achilles tendon and the anterior navicular bone asrelates to the talus.

The method of insertion for the hip joint invention may be a minimallyinvasive approach, ideally arthroscopically facilitated, as long as thesurgical timing and result quality permit smaller incisions. The hippatient may be placed in the lateral decubitus position (lyingnon-operative side down on the operating table) with a stabilizingoperating table pole and pad apparatus positioned to fix the pelvis. Theexternal stabilizing table and attachments may include a padded metalpole beneath the pubis or pelvic bone from posterior to anterior, alongwith other external anterior and posterior pelvic stabilizing paddles.The affected leg may be attached beneath the knee with a distractingmechanism that applies about 60 pounds of distal force to open the hipjoint about 1 cm once the patient is under general anesthesia. The hipjoint is arthroscopically debrided through at least one anterior 0.5 cmincision and one posterior 0.5 cm incision, to remove from the femoralhead acetabular (ball and socket) joint arthritic debris such assynovitis, loose bodies and noxious inflammatory enzymes. In certaincases a larger open incision may be needed. A smoothing orelectronic/ultrasonic/steam or other chondroplasty method may beperformed to make the remaining cartilage smoother to better accommodatethe hip implant, and protuberant osteophytes or lateral bone overgrowthsmay be arthroscopically removed or if needed by open excision. A lateralhip incision may be required between 2 and 10 centimeters in length todeal with deformities and/or to insert the implant. In cases of majordeformities appropriate reconstruction may add to the basic procedure.

Once the joint is open and cleared, the hip implant may be insertedlaterally and fixed via the skirt or tabs or at least one appendage tothe adjacent structures including the peripheral femoral head and/oracetabular rim. Preferably, the implant is inserted arthroscopicallythrough a cannula about 10 mm in diameter with the implant in thedeflated construct, and once inside the prepared joint space and securedtherein by the skirt or tabs, the implant may be distended or inflatedwith gas, gel, fluid or fluid that becomes a resilient solid to fill theoriginal natural space of about 0.5 cm between the upper acetabulum andlower femoral head, covering as much of the upper hip joint as requiredas the implant expands to fit the space.

The method of insertion of the ankle implant generally may be through ananterior surgical ankle approach or tendon separating incision from thedistal tibia to the proximal talus (or calcaneus if the talus isabsent), removing and reconstructing portions of the superior andinferior ankle extensor retinacula only to the extent required to gainaccess to the cleared tibiotalar space. Analogous to the hip jointinsertional method, the ankle joint may be prepared arthroscopicallyunder general anesthesia, and may benefit from distal distraction as intotal ankle joint replacement surgeries with the DePuy Agility techniquepinning above and below the ankle joint and then distracting it. Thedegree of distraction required in all joints to which this invention isapplied, including but not limited to those of all appendicular skeletalstructures such as the shoulder, elbow, wrist, phalanges, hip, knee, andankle, may depend both on the nature anatomy and located pathophysiologythat must be accommodated on a case by case basis and said distractionmay be a combination of body position using gravitational forces and/orsuperimposed distracting devices. In the ankle, the surgeon may bedeveloping the interval between the extensor hallucis longus andanterior tibial tendons. Injury tissue is removed, and the implantinserted fitting as preplanned. The implant surface may be provided withroughness, e.g. external mesh, to control movement by friction asdescribed above for the hip joint, and/or attached fixation cords ortabs to connect to proximate ligaments or adjacent boney structures maybe used at the surgeon's discretion to balance implant locationstability and integrity, with the need for functional joint movements.

Provided herein is a method for restoring a joint comprising: providingan implant configured for deployment between a first bone and at leastone second bone of a joint, the implant further comprising a ballooncomprising a first portion that is configured to engage the first boneof the joint, a second portion that is configured to engage at least onesecond bone of the joint, a side portion connecting the first portionand the second portion, in which the side portion facilitates relativemotion between the first portion and the second portion, and an interiorthat is optionally inflatable with a first inflation medium; andcoupling a first appendage of the balloon to the first bone of thejoint. In the case of a knee device, the first bone may be one of atibia, a femur and a patella. In the case of a knee device, the secondbone may be one of a tibia, a patella and a femur.

In some embodiments, at least two of first portion, the second portion,and the side portion are contiguous. In some embodiments, the firstportion comprises a first wall, the second portion comprises a secondwall, and the side portion comprises a side wall.

In some embodiments the method comprises providing an in-growth patch onat least one of the first portion configured to engage the first bone(e.g. a femur, a tibia, or a patella, in the case of the knee device),the second portion configured to engage the second bone, the sideportion, and the appendage. The in-growth patch may be configured toencourage and/or promote tissue in-growth, such as bone in-growth, fornon-limiting example. The patch may be as large as the portion itself(whether the first portion the second portion, the side portion, or theappendage) or may be smaller than the portion (such as in the shape of astrip or other shaped patch). The in-growth patch may comprise a surfaceirregularity or roughness. The in-growth patch may be Velcro-like. Insome embodiments the implant comprises an in-growth patch on the firstportion and/or the second portion, from (and in some embodimentsincluding) a first appendage to a second appendage. In some embodiments,wherein the appendages loosen from attachment from the bone (by designand/or from wear and/or over time), the in-growth patch aids in securingthe implant to the bone. In some embodiments, the in-growth patchcomprises beads and/or bead-like elements attached to the implant. Suchan in-growth patch may be configured to simulate trabecular bone spaceof a normally cancellous latticework. In some embodiments, the beads aresintered beads of various sizes. In some embodiments, the beads aresintered beads about 400 microns in size. With respect to bead size, theterm “about” can mean ranges of 1%, 5%, 10%, 25%, or 50%. In someembodiments, the first bone and/or the second bone is roughened toacquire a bleeding bone to facilitate in-growth. In some embodiments,about 0.5 mm of cortical tissue is removed to facilitate in-growth.

In some embodiments, the method comprises coupling a second appendage ofthe balloon to the first bone of the joint. In some embodiments, themethod comprises coupling a second appendage of the balloon to at leastone second bone of the joint. In some embodiments, the method comprisescoupling a second appendage of at least one of the first portion, thesecond portion, and the side portion to at least one of the first boneand at least one second bone of the joint. In some embodiments, couplingat least one of the first appendage and the second appendage providesligamentary-like support to the first bone and at least one second boneof the joint. In some embodiments, coupling at least one of the firstappendage and the second appendage provides ligamentary-like support tothe joint. In some embodiments, the first appendage and the secondappendage are configured to provide tendon-like support to the firstbone and the at least one second bone of the joint. In some embodiments,the first appendage and the second appendage are configured to providetendon-like support to the joint.

In some embodiments, the method comprises providing an inflation port incommunication with the interior of the balloon for inflation of theinterior of the balloon with the first inflation medium. In someembodiments, the method comprises using an inflation port of the implantthat is in communication with the interior of the balloon to inflate theinterior of the balloon with the first inflation medium. In someembodiments, the method comprises puncturing the balloon to inflate theinterior of the balloon with the first inflation medium. In someembodiments, the method comprises providing a balloon havingself-sealing capability. In some embodiments, the method comprisesproviding a balloon having self-sealing capability upon inflation of theinterior of the balloon with the first inflation medium. In someembodiments, the method comprises providing a balloon comprising a sealcapable of closing the interior of the balloon.

In some embodiments, the method comprises providing a balloon having aninterior comprising a plurality of inflatable chambers. In someembodiments, the interior comprises a plurality of individuallyinflatable chambers. In some embodiments, the method comprises inflatinga first chamber of the plurality of inflatable chambers with a firstinflation medium. In some embodiments, the first chamber and theinflation medium is selected based on the particular needs of thepatient. For non-limiting example, if the patient has bone loss due toan injury, the chamber may be selected at the location of the missingbone, and may be filled with a rigid inflation medium (or one thatbecomes rigid once in the chamber) in order to replace the missingand/or damaged bone. Alternatively, or in addition, a chamber may bechosen to restore alignment of the joint, and inflated with anappropriate inflation medium to impart both alignment and cushion to thejoint. In some embodiments, the method comprises inflating a secondchamber of the plurality of individually inflatable chambers with asecond inflation medium.

In some embodiments, the balloon is a composite structure. In someembodiments, the balloon comprises layers of porous and/or non-porousmaterials, or otherwise contains treatment or cell regeneration agents.In some embodiments, a first layer of the balloon is a thin, but stronglayer of a thermoplastic, such as a thermoplastic polyurethane, fornon-limiting example, which has microporosity sufficient to allowpassage or egress of treatment or cell regeneration agents from a secondlayer. The second layer may be a central layer (which lies between thefirst layer and a third layer or a fourth layer or more layers). Thefirst layer may comprise a bone engaging surface in some embodiments.The degree of microporosity to enable egress of treatment or cellregeneration agents from the second layer is found in polymer layerssuch as Chronoflex (e.g., ChronoFlexAR®, ChronoFlex AL®, ChronoFlec C®)or BIONATE (e.g., BIONATE I, BIONATE II, BIONATE 55D, BIONATE 65D,BIONATE 75D, BIONATE 80A, BIONATE 90A, BIONATE 55 or BIONATE 80). Thebone engaging surface of the implant may be coated and/or impregnatedwith a latticework of polymer that is surface sprayed or layered on thebone engaging surface of the implant to promote cartilage tissueregeneration. This bone engaging surface coating may contain livingchondrocytes (for example, as is provided in the Carticel procedure bythe Genzyme company), and/or may contain stem cells with directed genemutations to enhance adherence of the coating to the implant. The boneengaging surface may comprise peaks and troughs. The living cells may beprovided in troughs while the surface peaks may be used for at least oneof: space validation, traction, and cell protection.

In some embodiments, the first inflation medium imparts rigidity in theimplant. In some embodiments, the first inflation medium imparts cushionin the implant. In some embodiments, the inflation medium chosen for thefirst inflation medium, and/or the particular choice of chamber (inembodiments having multiple chambers) filled with such first inflationmedium aligns the joint. In some embodiments, the inflation mediumchosen for the first inflation medium, and/or the particular choice ofchamber (in embodiments having multiple chambers) filled with such firstinflation medium aligns the bones of the joint. In some embodiments, theinflation medium chosen for the first inflation medium, and/or theparticular choice of chamber (in embodiments having multiple chambers)filled with such first inflation medium changes the bone alignment. Insome embodiments, the inflation medium chosen for the first inflationmedium, and/or the particular choice of chamber (in embodiments havingmultiple chambers) filled with such first inflation medium improvesjoint alignment. In some embodiments, the inflation medium chosen forthe first inflation medium, and/or the particular choice of chamber (inembodiments having multiple chambers) filled with such first inflationmedium restores, at least in part, joint alignment. In some embodiments,individual chambers of the interior are selectively inflated with afirst inflation medium and/or a second inflation medium. In someembodiments, individual chambers of the interior are selectivelyinflated with a first inflation medium and/or a second inflation mediumin order to reconstruct the joint and/or in order to reconstruct bonesof the joint.

Over time, in-growth of repair tissue aids in fixation and stabilityexternally to the implant, while the soft cushioning implant interiormay absorb forces across the joint surfaces and permit proper motion.The turgor or wall tension of the implant as well as the insidedistension of the implant per se can be adjusted by adding or removingthe inflation substance to the implant's interior space.

Accordingly, the present invention provides a new approach toarthroplasty that involves a resilient implant deployed between bones ofthe knee joint. In some instances, a joint is comprised of the interfacebetween (a) a first bone and a first cartilage; and (b) a second boneand a second cartilage, wherein the first cartilage is separated fromthe second cartilage by a space (e.g., joint space) and the cushionexpands to fit the joint space. In some instances, where the firstcartilage and/or second cartilage is damaged or absent, the cushionexpands to fit the joint space between the first bone and secondcartilage or the first bone and second bone. In certain joint spacessuch as the knee, the cushion expands to fit the spaces of the “kneejoint” or “knee joints”. For example, the cushion may expand to fit thespaces of the femoral tibial involved on standing or walking on a levelplane, and the cushion may expand to fit the spaces of the patellafemoral bones of the knee more involved on stair ascent and descent. Forexample, pressures behind the knee cap or patella when lying are zero,when standing are 0.7 times body weight, and when going up and down thepatella femoral pressures are 3-4 times body weight. Thus, in someinstances, the implants accommodate some or all of the normal bodyfunctional pressures and complex space movements, as described above,and can also be used in other joints such as the elbow, ankle, or hip.When in the hip joint, the normal flexion up to 120 degrees, extensionof 20 degrees, abduction of 50 degrees, internal and external rotationof 45 degrees may produce variable axial, shear, and cyclic loads whichthe implant by design may accommodate and endure as up to 6 times bodyweight, consistent with a tire on a car that allows for cyclic loadsdifferent when driving straight or turning corners. The implantembodying features of the present invention provides more physiologicmotion and shock absorption within the joint and has combinedcharacteristics of anatomic design symmetry, balanced rigidity withsufficient attachment connections to adjacent normal structures, anddurability that meet the needs of joint reconstruction.

The opposing internal surfaces of the first and second walls of theinvention may either move together in synchrony or in oppositedirections from one another (e.g. the superior wall moving medially inthe hip and the inferior wall moving laterally). Optionally, the implantmay be fixed to a concave surface of the joint (e.g., the acetabular hipcup) or to a convex surface of the joint (e.g. the dorsal femoral headsurface), to both, or to neither (e.g., having an interference fitwithin the joint with an expanding balloon or cushion that fills theexisting space). The implant may be inserted arthroscopically like adeflated balloon and then inflated through a cannula into the ankle orhip (or other joint structure) to act as a cushion or renewed interfacefor painless and stable limb motion. When feasible, joint capsular andadjacent ligament tissue as well as bone may be left in place topreserve the natural body, unless interfering with reconstructed limbfunction.

The application of steam in addition to removing damaged debris, cansmooth out and reform the joint surface. The high temperature of thesteam tends to weld cracks or fissures which can be present in thecartilage surface of a damaged joint. Smoothing of joint surfacecartilage with steam welds or seals existing cracks or flaps in thecartilage, especially superficially as the lamina splendors, which melttogether to provide a white shiny gliding joint surface. In cases wherebone is exposed, the steam can be used to stabilize the periphery of thedefect in the joint surface via capsulorrhaphy or joint tightening. Openmechanical and chemical debridement may also be employed to prepare thesurfaces for the implant.

Once the implant is secured to the femur by means of the skirt or tabsor using other couplers, an impregnated transfer medium or cell templatemay be used, as described by Histogenics and Tygenix chondrocytesdelivery systems wherein the position of concentrated cells ismechanically placed about the implant at areas of greatest cartilagedamage to promote regrowth, or as in Carticel wherein watery cells areimplanted beneath a periosteal membrane (a wall of the implant servingas the membrane), prior to completion of the inflation or expansion ofthe implant. A syringe or gauged device with measured screw-homepressure is used to inflate the implant.

Once the joint is ready to receive the implant, the deflated implant isadvanced through the diaphragm of a delivery cannula (such as the Acufexfrom Smith & Nephew) or through the open incision site into the joint.It can be inflated by the attached cannula using a common syringe,inserting several cc's of filler material. Inserted contents andlocations of cell placements depend on areas of need and joint size. Insome embodiments of the methods several cc's of filler material and aviscolubricant in the interior of the implant allows distension,cushioning, and gliding movements. Cell regeneration agents are placedin the areas of greatest need.

Methods of living cell (e.g., stem cell, differentiated cell,pluripotent cell, post-mitotic cell) or chondrocyte placement depend onthe lesions and specific implant construct. Direct infusion into thejoint with completion of implant inflation may press the cells into thehyaline surface, whereupon they attach within the first 24 hours. As aresult, the patient may be forced to remain sedentary and the jointwhere the implant is deployed, non-weight bearing for the first dayafter surgery. Deeper osteochondral defects can be treated by‘hyper-perfusion of cells’ via either 3-D cell transfer templates, ormicroneedle injection as used in treatment of diabetic patients forblood sugar testing and insulin/transdermal drug delivery. In cases ofosteochondritis dissecans or localized both cartilage and bone lose,bone graft may be packed into the base of the defect followed byaddition of a cell/tissue application. The cannula attached to theimplant may be sealed and detached, or left in place for periodicaspiration of noxious enzymes as for the Cox-1, Cox-2, and 5-Loxsystems, followed by reinsertion of activated substances includingviscolubricants, or even more cells (e.g., stem cells, differentiatedcells, pluripotent cells, post-mitotic cells).

Implants embodying features of the invention may be designed forpermanent or temporary deployment within a joint structure. Moreover,the implant may be formed of suitable bioabsorbable materials so thatthe implant may be absorbed within a particular predetermined timeframe. Suitable bioabsorbable materials include polylactic acid,polyglycolic acid, polycaprolactone, copolymers, blends and variantsthereof. One present method of forming the implant is to apply numerouslayers of polymer such as ChronoFlex (e.g., ChronoFlexAR®, ChronoFlexAL®, ChronoFlec C®), ChronoPrene™, ChronoSil®, ChronoThane P™,ChronoThane T™, HydroMed™, HydroThane™, or PolyBlend™ in a solvent andevaporating the solvent after applying each layer.

The coupling aspects (couplers) including but not limited to skirting orfixation tabs of the present implant prevent joint migration during use.

In some embodiments, the implant is adapted to restore natural jointfunction. In some embodiments, the implant is adapted to preserve viablejoint tissue. In some embodiments, the implant is adapted to be placedwith minimal surgery as compared to joint replacement therapy currentlymarketed. In some embodiments, the implant is adapted to permit weightbearing post surgery within at least one of: about 1 week, within about1 day, within about 2 days, within about 3 days, within about 4 days,within about 5 days, within about 6 days, within about 10 days, withinabout 2 weeks, within about 3 weeks, within about 4 weeks, within about5 weeks, within about 6 weeks. In some embodiments, the implant isadapted to permit weight bearing post surgery after about 1 day whereinfull weight bearing is allowed in about 6 weeks. As used herein withrespect to weight bearing timing, the term “about” can be a range of 1day, 2 days, or 3 days, in some embodiments. In some embodiments, theimplant is adapted to allow for faster recovery and resumption of normalactivities as compared to joint replacement therapy currently marketed.

In some embodiments, the balloon (or a portion thereof) is adapted toconform to the patient's anatomy. In some embodiments, the implant (or aportion thereof) is adapted to conform to the patient's anatomy. In someembodiments, the inflation medium is adapted to absorb a force (orforces) exerted on the joint. In some embodiments, the inflation mediumis adapted to absorb a force (or forces) exerted on the bones of thejoint. In some embodiments, the inflation medium is adapted to absorb aforce (or forces) exerted on at least one bone of the joint. In someembodiments, the balloon is adapted to absorb shocks exerted on at leastone of a bone, multiple bones, a ligament of the joint, ligaments of thejoint, a tendon of the joint, tendons of the joint, and the joint ingeneral. In some embodiments, the implant is adapted to restore naturalcartilage cushion with cells (e.g., stem cells, differentiated cells,pluripotent cells, post-mitotic cells). In some embodiments, the implantis adapted to restore natural cartilage cushion with stem cells.

In some embodiments, the balloon (or a portion thereof) is adapted torenew joint space. In some embodiments, the balloon (or a portionthereof) is adapted to reduce pain as compared to the pain felt prior tothe implantation of the implant. In some embodiments, the balloon (or aportion thereof) is adapted to restore joint function. In someembodiments, the implant (or a portion thereof) is adapted to renewjoint space. In some embodiments, the implant (or a portion thereof) isadapted to reduce pain as compared to the pain felt prior to theimplantation of the implant. In some embodiments, the implant (or aportion thereof) is adapted to restore joint function.

In some embodiments, the implant is adapted to reverse arthritis in thejoint. In some embodiments, the implant is adapted to prevent, reduce,or ameliorate arthritis in the joint. In some embodiments, the implantis adapted to reduce pain associated with arthritis in the joint.

In some embodiments, the balloon (or a portion thereof) is adapted to beplaced into a debrided limb joint arthroscopically. In some embodiments,the balloon is adapted to pad cartilage defects. In some embodiments,the balloon is inflated to cushion the joint. In some embodiments theimplant is adapted to deliver stem cells to at least one of the jointand a bone of the joint. In some embodiments the implant is adapted todeliver living chondrocytes to at least one of the joint and a bone ofthe joint. In some embodiments, the implant is adapted to deliver cellsto at least one of the joint and a bone of the joint. In someembodiments, the cells are at least one of stem cells, differentiatedcells, pluripotent cells, and post-mitotic cells. In some embodiments,the implant is adapted to provide a new articular surface for the joint.In some embodiments, the implant is adapted to act as a spacer in thejoint. In some embodiments, the implant is adapted to space the bones ofthe joint apart for proper joint articulation. In some embodiments, theimplant is adapted to space the bones of the joint apart for reducedbone-on-bone rubbing.

In some embodiments, the implant is configured to at least one of: padcartilage, cushion the joint, deliver a pharmacologic substance, removenoxious enzymes, debride upon implantation, debride the joint followingimplantation, deliver a therapeutic substance, deliver a biologicsubstance, and deliver living stem cells. In some embodiments, theimplant is configured to deliver a chemotherapeutic agent to a bone orother surrounding tissues. In some embodiments, the implant isconfigured to deliver an anti-infectious medication to a bone or othersurrounding tissues. In some embodiments, the implant is configured todeliver at least one of an antibiotic, antifungals, and analgesicsagent.

In some embodiments, the implant is configured to be selectivelyinflated to realign limbs.

Provided herein is a method comprising: implanting a knee implant asdescribed herein into a subject, wherein the implant reverses arthritisin the subject. Provided herein is a method comprising: implanting aknee implant as described herein into a subject, wherein the implantprevents, reduces, or ameliorates arthritis in the subject. Providedherein is a method comprising: implanting a knee implant as describedherein into a subject, wherein the implant reduces pain associated witharthritis in the subject.

Provided herein is a method comprising: implanting a knee implant asdescribed herein into a knee joint of a subject and treating a componentof the knee joint of the subject with at least one of an allographtissue, an autograph tissue, and an xenograph tissue. In someembodiments, the tissue comprises a cell. In some embodiments, thetissue comprises a plurality of cells. In some embodiments, the cell isa stem cell, differentiated cell, pluripotent cell, or post-mitoticcell. In some embodiments, the implanting step is at least one of: priorto the treating step, simultaneous with the treating step, and followingthe treating step.

Provided herein is a method comprising: implanting a knee implant asdescribed herein into a subject, wherein the implant is configured to atleast one of: restore joint function and control arthopathies. In someembodiments, the implanting spares existing anatomy.

Provided herein is a method comprising: debriding a femur condyle of aknee joint of a subject, and implanting a knee implant as describedherein into the knee joint of the subject, whereby the implant isconfigured to anneal to the cartilage of the subject. In someembodiments, the debriding is achieved by steam application.

Provided herein is a method comprising implanting a knee implant asdescribed herein into a joint previously treated with a jointreplacement. In some embodiments, the method comprises removing thejoint replacement prior to implanting the knee implant. In someembodiments, the method comprises clearing infectious matter from thejoint and/or surrounding tissues. In some embodiments, the methodcomprises implanting a second implant of any implant described hereinfollowing removing the implant previously implanted in the joint. Insome embodiments, the method comprises replacing the joint of thesubject following removing the implant previously implanted in thejoint. In some embodiments, the method comprises debriding the bone ofthe joint, and implanting an implant of any implant described herein. Insome embodiments, the method comprises repeating the debriding andimplanting steps.

The surgical techniques may be individualized to fit patient need. Theimplants may be combined with or comprise autologous or allographtissues such as fascia lata. Surgeons may implant fascia lata aboveunreconstructable rotator cuff with consequent symptom relief Polymerscan interface with any human tissue and/or with metals or polyethylenesor polyurethanes. Living tissues that can be combined with implantsprovided herein for repair or reconstruction may be from the samepatient (autograph), and cadaver or other member of the same species(allograph) or from another species (xenograph.) Virtually anycombination of polymer interpositioning is feasible with the implantconcepts provided herein, as anatomy varies among patients in need, andclinical conditions differ with each person. Therefore, although thegeneral or most common construct is expected to cover just one singularand the primary surface of a joint with an implant, any combination ofsurfaces can be involved allowing versatile custom applications of thisimplant and method of surgery.

Additionally, whereas implants may be available in specified sizes, thematerial membrane elastic deformation and resilience may allow forcalculated malleability toward goodness of fit. In other iterations thefit of implant over the affected joint surface can be customized asparing preoperative findings of MRI or CT or PET imaging pathophysiologywith intraoperative reconstructive need. Ultimately best fit implantsmay serve patient restorative requirement with least morbidity.

The implants may be implanted typically during an outpatient surgery,wherein the joint is first arthroscopically debrided and cartilageprepared, similar to the methods used in a Carticel procedure. Cartilageor osteochondral size defects and alignment problems are studied, andmeasurements taken. Considerations to materials stretch are acknowledgedas polyurethanes gain 50% pliability with 100 hours exposure to serum,and 30% additional malleability by heating to 37 degrees C. Thus,implant presentation in the OR may aim for best fit and accommodatepatient need.

Intraoperative hyaline cartilage biopsy acquiring e.g. 400 mg of normalhyaline articular tissue from the intercondylar notch (as would bewasted with notchplasty) or from the joint periphery (outsidearticulating regions) may allow for chondrocytes autologous acquisition.Currently such specimens may be sent to Genzyme Corp. for 2-4 weekscloning of cells whereupon 2-3 bottles containing e.g. 1 cc of cells,93% viability, 12 million cells per bottle, are delivered on an exactday to the operating room for placement in the Carticel cartilageregenerative procedure securing the liquid cells beneath a harvestedperiosteal membrane. In implant surgery contemplated in certainembodiments, the polymer may substitute for the periosteum thus reducingsurgical morbidity markedly and changing an otherwise major openprocedure into an arthroscopically facilitated outpatient treatmentoption through a small arthrotomy.

With outpatient surgeries the intraoperative biopsy may be given to thetechnician in the operating room in early surgery, for insertion intothe stem cells generation machine. In 30-40 minutes living autologouschondrocytes may be ‘spun down’ and separated, then returning the livingcells to the primary surgeon. By this time, the implant has been pulledup over the prepared defects and sufficient fixation sites have beenlocked into place so that the implant is secure in its general locationover the distal femoral surface, for example. An unattached portion ofthe implant is lifted, the newly procured cells inserted potentially ona soft matrix to hold cells inside the prepared defect, and theimplantation is completed sealing the living cells for the purpose ofarticular surface regeneration. After 24 hours the cells are fixed asthe aggregate to the surface of the defect into which they wereintroduced. This begins a one year period of regrowth of the new jointsurface. Concurrently the arthritis osteochondral defect so treated ispadded by the implant, and the joint cushioned is mechanically restored.Said cushioning is by nano and/or macro inflation and/or by use ofpolymers with variable compliance. Immediate fixation and theopportunity for a regenerated joint are thus accomplished in theoperating room. This may use either the implant matched to size bypreoperative planning via X-rays considering the magnification factors,by using one of the other scanning methods available, or by customgeneration ultimately of implant partial or entire coverage options inthe same surgery.

Once the implant is secured circumferentially and solidly in place withmultiple fixation sites verified as patent, one or two forms oforthobiologic activity proceed. Specifically, if chondrocytes wereimplanted (autologous or potentially allograph) they may mature and inthe course of a year the durometry may come to resemble normal hyalinearticular cartilage. The other biologic activity promoted duringimplantation surgery is the bone in-growth onto the tab undersurfaceand/or periphery. This fixation at the secondary level in proposed todecrease the probability of loosening of the prosthetic implant, one ofthe two most common causes of implant failure. With the normal 10,000steps people take per day during normal gait, or 2-4 million cycles perannum, the compressive and shear forces, and cyclic loads can causemicromotion between the implant and natural underlying tissue. This maylead to implant shift, dislocation, and/or hardware backing out if notappropriately secured to the bones. In the implant technique theimmediate fixation is achieved through multiple robust circumferentialfixation of implant tabs to bone. Each screw and washer secures themechanically adequate implant tab to bone at over 300 pounds force tofailure. Since, depending on the embodiment, there may be ten (10) tabsites intended the sum of 3000 pounds. In some embodiments, fixationcomprises bone in-growth. In some embodiments, the fixation comprisesbone in-growth as described in Vasanji A, In vivo bone growth assessmentin preclinical studies and clinical trials, Bonezone, 2012, p. 12-17,herein incorporated by reference in its entirety.

The methods of surgery may have certain constants and other variablesmandated by materials and fixation management versus altering anatomiesand joint forces. In each joint a standardized implant method of surgerymay be recommended with variations to be determined by the responsiblesurgeon.

While particular forms of the invention have been illustrated anddescribed herein, it will be apparent that various modifications andimprovements can be made to the invention. One alternative implantconstruction involves the use of an upper portion of the implant havinga net-like construction and filled with balls or ball bearing likeelements that are larger than the openings in the netting. The balls orball bearing like elements provide motion to the implant. The nettingand ball bearing like elements may include regeneration agents aspreviously discussed, and the bearing construction may be directedtoward favorable implant movement balanced with content disbursement.

The invention is intended primarily for human use but may be extended tomammalian use. Examples of mammals include, but are not limited to,cats, dogs, sheep, horses, pigs, goats, cows, mice, and rats. To theextent not otherwise disclosed herein, materials and structure may be ofconventional design.

Moreover, individual features of embodiments of the invention may beshown in some drawings and not in others, but those skilled in the artwill recognize that individual features of one embodiment of theinvention can be utilized in another embodiment. Moreover, individualfeatures of one embodiment may be combined with any or all the featuresof another embodiment. Accordingly, it is not intended that theinvention be limited to the specific embodiments illustrated. It istherefore intended that this invention be defined by the scope of theappended claims as broadly as the prior art will permit.

Terms such as “element”, “member”, “component”, “device”, “means”,“portion”, “section”, “steps” and words of similar import when usedherein shall not be construed as invoking the provisions of 35 U.S.C§112(6) unless the following claims expressly use the terms “means for”or “step for” followed by a particular function without reference to aspecific structure or a specific action. All patents and all patentapplications referred to above are hereby incorporated by reference intheir entirety.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

1. An implant configured for deployment between a femur and a tibia of aknee joint, the implant comprising a first portion that is configured toengage a medial condyle and a lateral condyle of the femur of the kneejoint, a second portion that is configured to engage the tibia of theknee joint, a first appendage on the medial condyle configured to couplethe first portion to the femur of the knee joint, a second appendage onthe lateral condyle configured to couple the first portion to the femurof the knee joint, and a slot between the first appendage and the secondappendage, wherein the first appendage and the second appendage cushionthe femur and tibia. 2.-5. (canceled)
 6. The implant of claim 1, whereinthe second appendage further couples the first portion to the tibia ofthe joint.
 7. (canceled)
 8. An implant configured for deployment betweena femur and a patella of a knee joint, the implant comprising a firstportion that is configured to engage at a trochlear groove of the femurof the knee joint, a second portion that is configured to engage thepatella of the knee joint, a first appendage on the medial condyle ofthe femur configured to couple the first portion to the femur of theknee joint, a second appendage on the lateral condyle of the femurconfigured to couple the first portion to the femur of the knee joint,and a slot between the first appendage and the second appendage, whereinthe implant cushions the femur and patella.
 9. An implant configured fordeployment between a tibia and a patella of a knee joint, the implantcomprising a first portion that is configured to engage at a tibia ofthe knee joint, a second portion that is configured to engage thepatella of the knee joint, a first appendage configured to couple thefirst portion to the tibia of the knee joint, a second appendageconfigured to couple the first portion to the tibia of the knee joint,and a slot between the first appendage and the second appendage, whereinthe implant cushions the tibia and patella.
 10. The implant of claim 1,further comprising an in-growth matrix on at least a portion of theimplant adjacent the femur.
 11. The implant of claim 10, wherein thein-growth matrix comprises living chondrocytes.
 12. The implant of claim11, wherein the implant is configured to release the chondrocytes overtime.
 13. The implant of claim 11, wherein the implant comprises abioabsorbable polymer configured to release the chondrocytes over time.14. The implant of claim 11, wherein the implant comprises a polymerconfigured to release the chondrocytes over time, wherein the polymer isnot bioabsorbable.
 15. The implant of claim 11, wherein the in-growthmatrix comprises at least one of: autologous cells, allograph cells, andxenograph cells to restore an articular surface of the femur.
 16. Theimplant of claim 11, wherein the in-growth matrix comprises at least oneof: autologous cells, allograph cells, and xenograph cells to repair anarticular surface of the femur.
 17. (canceled)
 18. The implant claim 1,further comprising a bioabsorbable coupler.
 19. The implant of claim 1,wherein the coupler is at least one of: a screw, a washer, a suture, asuture anchor, a snap, a rivet, a staple, a staple having teeth, astabilizer, a glue, a hook, a wire, a string, a lasso, a lanyard, aspike, and combinations thereof. 20.-22. (canceled)
 23. The implant ofclaim 1, further comprising a pharmacologic agent.
 24. The implant claim23, wherein the pharmacologic agent is on a surface of the implantadjacent the femur.
 25. The implant claim 23, wherein the pharmacologicagent is released from the implant over time. 26.-29. (canceled)
 30. Theimplant of claim 1, further comprising chondrocytes.
 31. The implant ofclaim 1, wherein at least a portion of the implant is configured toanneal to a periphery of a cartilage defect.
 32. The implant of claim 1,wherein the implant comprises vacuoles of pharmacologic substances.33.-60. (canceled)